Trial Outcomes & Findings for Efficacy and Safety of Intranasal MSP-2017 (Etripamil) for the Conversion of PSVT to Sinus Rhythm (NCT NCT02296190)

Last Updated: 2020-12-30

Results Overview

The primary efﬁcacy endpoint was the rate of successful PSVT conversion to sinus rhythm lasting at least 30 seconds within 15 minutes of study drug administration after a minimum of 5 minutes in sustained PSVT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

199 participants

Primary outcome timeframe

Within 15 minutes of study drug administration

Results posted on

2020-12-30

Participant Flow

Adults aged 18 years and older with Paroxysmal supraventricular tachycardia (PSVT) who met the study inclusion/exclusion criteria. Study was initiated on March 27, 2015 and completed on December 8, 2016 and was performed in electro-physiology clinics in the USA and Canada.

Participant milestones

Participant milestones
Measure	Etripamil_140 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_ 105 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Open-label Etripamil 70 mg 9 subjects were assigned to an open-label Sub-study Safety Population. Subjects participating in the open-label sub-study received intra nasal administration of 70 mg MSP-2017 (total) via 2 prefilled Aptar Pharma Unit-Dose Spray devices.
Overall Study STARTED	35	41	35	43	36	9
Overall Study COMPLETED	21	20	23	20	20	9
Overall Study NOT COMPLETED	14	21	12	23	16	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etripamil_140 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_ 105 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Failure to induce PSVT	6	10	5	13	8
Overall Study Physician Decision	1	1	0	1	2
Overall Study Withdrawal by Subject	0	1	0	0	0
Overall Study PSVT < 5 minutes	5	6	6	6	5
Overall Study Patient was given Propofol	0	1	0	1	0
Overall Study Patient with Atrial Tachycardia	0	0	0	1	0
Overall Study Blood pressure <100 after sedation	0	0	0	1	0
Overall Study Atrial Tachycardia induced not PSVT	0	1	1	0	0
Overall Study Patient on antiarrhythmic medication	1	0	0	0	0
Overall Study Failed PSVT with mechanism of AVNRT	0	1	0	0	0
Overall Study Lab result not available in time	1	0	0	0	0

Baseline Characteristics

Efficacy and Safety of Intranasal MSP-2017 (Etripamil) for the Conversion of PSVT to Sinus Rhythm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etripamil_140 mg n=21 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_105 mg n=20 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg n=23 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg n=20 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo n=20 Participants 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Open- Label Etripamil 70 mg n=9 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Total n=113 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	18 Participants n=21 Participants	9 Participants n=8 Participants	96 Participants n=8 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	17 Participants n=8 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	65 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants	3 Participants n=8 Participants	48 Participants n=8 Participants
Race/Ethnicity, Customized WHITE	17 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	18 Participants n=21 Participants	7 Participants n=8 Participants	91 Participants n=8 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	14 Participants n=8 Participants
Race/Ethnicity, Customized OTHER	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Race/Ethnicity, Customized ASIAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment Canada	4 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants	4 participants n=21 Participants	0 participants n=8 Participants	26 participants n=8 Participants
Region of Enrollment United States	17 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants	13 participants n=4 Participants	16 participants n=21 Participants	9 participants n=8 Participants	78 participants n=8 Participants

PRIMARY outcome

Timeframe: Within 15 minutes of study drug administration

Population: The efficacy analysis was based on the Evaluable Population which included all randomized subjects who were induced and sustained Supraventricular tachycardia (SVT) for 5 minutes, received the study drug, and completed the assessment of conversion to sinus rhythm. The "Open- Label Etripamil 70 mg" group was not part of the Evaluable Population, as the subjects did not meet the criteria of having sustained Supraventricular tachycardia (SVT) for 5 minutes.

Outcome measures

Outcome measures
Measure	Etripamil_140 mg n=21 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_ 105 mg n=20 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg n=23 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg n=20 Participants 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo n=20 Participants 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
The Percentage of Subjects Successfully Converted From PSVT to Sinus Rhythm Within 15 Minutes of Study Drug Administration	20 Participants	15 Participants	20 Participants	13 Participants	7 Participants

Adverse Events

Etripamil_140 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Etripamil_105 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Etripamil_70 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Etripamil_35 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Open Label Etripamil 70 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etripamil_140 mg n=21 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_105 mg n=20 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg n=23 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg n=20 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo n=20 participants at risk 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Open Label Etripamil 70 mg n=9 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
Cardiac disorders Bundle Branch Block Right	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter site haematoma	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Syncope	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.

Other adverse events

Other adverse events
Measure	Etripamil_140 mg n=21 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_105 mg n=20 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_70 mg n=23 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Etripamil_35 mg n=20 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Placebo n=20 participants at risk 1 dose of Placebo via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.	Open Label Etripamil 70 mg n=9 participants at risk 1 dose of Etripamil via 4 prefilled Aptar Pharma Unit-Dose Nasal Spray devices.
Cardiac disorders Atrioventricular block second-degree	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Vascular disorders Hypotension	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	38.1% 8/21 • Number of events 8 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	35.0% 7/20 • Number of events 7 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	47.8% 11/23 • Number of events 11 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	60.0% 12/20 • Number of events 12 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	66.7% 6/9 • Number of events 6 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	38.1% 8/21 • Number of events 8 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	45.0% 9/20 • Number of events 9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	26.1% 6/23 • Number of events 6 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	25.0% 5/20 • Number of events 5 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	44.4% 4/9 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	42.9% 9/21 • Number of events 9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	20.0% 4/20 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	30.4% 7/23 • Number of events 7 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	25.0% 5/20 • Number of events 5 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	19.0% 4/21 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	17.4% 4/23 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	17.4% 4/23 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Dysgeusia	14.3% 3/21 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Eye disorders Increased lacrimation	23.8% 5/21 • Number of events 5 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	17.4% 4/23 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	20.0% 4/20 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	8.7% 2/23 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Nausea	14.3% 3/21 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	13.0% 3/23 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Increased Upper Airway Secretion	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Throat Irritation	19.0% 4/21 • Number of events 4 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	35.0% 7/20 • Number of events 7 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	34.8% 8/23 • Number of events 8 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	45.0% 9/20 • Number of events 9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Upper -Airway Cough Syndrome	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Headache	14.3% 3/21 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	15.0% 3/20 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	13.0% 3/23 • Number of events 3 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Dizziness	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Rhinalgia	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	8.7% 2/23 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	9.5% 2/21 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Sneezing	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Throat Tightness	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Migraine	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Paraesthesia	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Dysphagia	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Enlarged uvula	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Oral Discomfort	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Vascular disorders Facial Flushing	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Oral Pain	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Palatal Swelling	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Ear and labyrinth disorders Ear Discomfort	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Chest Discomfort	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter site extravasation	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	11.1% 1/9 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Cerebrovascular disorder	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Nervous system disorders Sedation	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Eye disorders Vision Blurred	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Eye disorders Visual Impairment	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Constipation	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Cardiac disorders Bundle Branch Block Right	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter Site Haematoma	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter site pain	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	4.3% 1/23 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter site related reaction	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	8.7% 2/23 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Catheter site bruise	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
General disorders Vascular complication associated with device	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	10.0% 2/20 • Number of events 2 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Musculoskeletal and connective tissue disorders Neck Pain	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Vascular disorders Hypertension	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Vascular disorders Neurogenic Shock	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Cardiac disorders Atrioventricular Block Complete	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Injury, poisoning and procedural complications Post Procedural Complications	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Renal and urinary disorders Urinary Retention	4.8% 1/21 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/21 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	5.0% 1/20 • Number of events 1 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/23 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/20 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.	0.00% 0/9 • Adverse events were monitored from the time of study drug administration (Treatment Visit Day 1) until study participation completed at the Follow-up Visit which occurred from 12 hours to up to 5 days after the Treatment Visit. Maximum time frame 6 days.

Additional Information

Francis Plat _MD_Chief Medical Officer

Milestone Pharmaceuticals

Phone: 514-336-0444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place