Trial Outcomes & Findings for Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (NCT NCT03248440)

Last Updated: 2021-08-05

Results Overview

Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

263 participants

Primary outcome timeframe

Baseline to Day 15 ± 1

Results posted on

2021-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo TDS Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
Overall Study STARTED	131	132
Overall Study COMPLETED	116	120
Overall Study NOT COMPLETED	15	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo TDS n=131 Participants Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS n=132 Participants SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	Total n=263 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 17.00 • n=5 Participants	49.0 years STANDARD_DEVIATION 16.03 • n=7 Participants	47.9 years STANDARD_DEVIATION 16.52 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	81 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Race/Ethnicity, Customized White	88 Participants n=5 Participants	90 Participants n=7 Participants	178 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial (no primary race)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	131 participants n=5 Participants	132 participants n=7 Participants	263 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 15 ± 1

Population: Intent-to-treat (ITT) population included all randomized participants.

Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Outcome measures

Outcome measures
Measure	SUN-131 1.5% TDS n=132 Participants SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	Placebo TDS n=131 Participants Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1	32 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline to Day 15 ± 1

Population: Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion.

Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Outcome measures

Outcome measures
Measure	SUN-131 1.5% TDS n=95 Participants SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	Placebo TDS n=81 Participants Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1	27 Participants	14 Participants

Adverse Events

Placebo TDS

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

SUN-131 1.5% TDS

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Takahiro Ogawa, PhD

Senju USA, Inc.

Phone: +1 818 719 7190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator will not disclose information regarding this clinical investigation, or publish results of the investigation without authorization from Senju USA, Inc.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo TDS n=131 participants at risk Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS n=132 participants at risk SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
Eye disorders Chalazion	3.1% 4/131 • Number of events 6 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	1.5% 2/132 • Number of events 2 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Conjunctival follicles	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Ocular hypertension	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Pinguecula	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Vision blurred	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	1.5% 2/132 • Number of events 2 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Blepharitis	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Blepharospasm	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Conjunctival hyperaemia	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Dry eye	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Eye irritation	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Eyelid disorder	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 2 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Eyelid pain	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
General disorders Application site discomfort	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
General disorders Pain	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
General disorders Swelling	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
General disorders Application site erythema	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	3.8% 5/131 • Number of events 5 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	1.5% 2/132 • Number of events 2 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Nervous system disorders Headache	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Nervous system disorders Paraesthesia	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Cardiac disorders Tachycardia	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Ear and labyrinth disorders Ear congestion	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.00% 0/132 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Gastrointestinal disorders Tooth loss	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	0.76% 1/131 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	1.5% 2/132 • Number of events 2 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Bronchitis	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Ear infection	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Reproductive system and breast disorders Adnexa uteri pain	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Vascular disorders Hypertension	0.00% 0/131 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.	0.76% 1/132 • Number of events 1 • The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3). A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.