Trial Outcomes & Findings for Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT). (NCT NCT03464019)

NCT ID: NCT03464019

Last Updated: 2024-07-12

Results Overview

The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1097 participants
• Primary outcome timeframe: NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing.
• Results posted on: 2024-07-12

Participant Flow

431 participants enrolled in Part 1 until the 150th positively adjudicated PSVT episode (15-Jan-2020). After the Part 1 cutoff, 82 participants enrolled in Part 1 transitioned to Part 2 in addition to 624 newly enrolled participants until the 180th positively adjudicated PSVT in Part 2 (20-Jul-2022). The study continued for about 6 months (Part 3) after the Part 2 cutoff with participants waiting for a PSVT episode to arise and 42 newly enrolled participants (27-Feb-2023).

Participants had to pass a Test Dose before being randomized in the study. 431 participants received the etripamil 70 mg Test Dose before the Part 1 data cutoff. 672 participants received the RAPID etripamil 2x70mg Test Dose before the Part 2 cutoff; including 48 that transitioned from Part 1. An additional 42 participants received the RAPID etripamil 2x70mg Test Dose in Part 3. Participants failing the Test Dose due to safety/tolerability reasons were not randomized in the study.

Participant milestones

Measure	Placebo Self-administration of placebo for a perceived episode of PSVT during the randomized treatment period Part 1: single dose. Part 2 and Part 3: single dose followed 10 minutes later by an optional second dose of placebo, if symptoms persisted.	Etripamil Self-administration of etripamil for a perceived episode of PSVT during the randomized treatment period. Part 1: single dose etripamil 70 mg. Part 2 and Part 3: single dose 70 mg followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted.	Test Dose Only Single Test Dose of etripamil in sinus rhythm before randomization Part 1: single dose etripamil 70 mg. Part 2 and Part 3: single dose 70 mg followed 10 minutes later by a second dose of etripamil 70 mg.
NODE-301 Part 1 STARTED	60	138	233
NODE-301 Part 1 Participants Randomized	60	138	233
NODE-301 Part 1 Participants in Efficacy Population	49	107	0
NODE-301 Part 1 COMPLETED	60	138	0
NODE-301 Part 1 NOT COMPLETED	0	0	233
NODE-301 Part 2 and Part 3 STARTED	143	160	445
NODE-301 Part 2 and Part 3 Participants Randomized	143	160	445
NODE-301 Part 2 and Part 3 Participants in Efficacy Population	100	114	0
NODE-301 Part 2 and Part 3 COMPLETED	76	81	0
NODE-301 Part 2 and Part 3 NOT COMPLETED	67	79	445

Reasons for withdrawal

Measure	Placebo Self-administration of placebo for a perceived episode of PSVT during the randomized treatment period Part 1: single dose. Part 2 and Part 3: single dose followed 10 minutes later by an optional second dose of placebo, if symptoms persisted.	Etripamil Self-administration of etripamil for a perceived episode of PSVT during the randomized treatment period. Part 1: single dose etripamil 70 mg. Part 2 and Part 3: single dose 70 mg followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted.	Test Dose Only Single Test Dose of etripamil in sinus rhythm before randomization Part 1: single dose etripamil 70 mg. Part 2 and Part 3: single dose 70 mg followed 10 minutes later by a second dose of etripamil 70 mg.
NODE-301 Part 1 Withdrawal by Subject	0	0	18
NODE-301 Part 1 Ablation	0	0	16
NODE-301 Part 1 Test Dose Failure	0	0	8
NODE-301 Part 1 Adverse Event	0	0	5
NODE-301 Part 1 Physician Decision	0	0	4
NODE-301 Part 1 Lost to Follow-up	0	0	3
NODE-301 Part 1 Protocol Violation	0	0	2
NODE-301 Part 1 Reason was not provided by the participant	0	0	15
NODE-301 Part 1 Transitioned to Part 2 (RAPID)	0	0	82
NODE-301 Part 1 Participants did not experienced PSVT before cutoff and did not enroll in Part 2	0	0	80
NODE-301 Part 2 and Part 3 Withdrawal by Subject	5	1	32
NODE-301 Part 2 and Part 3 Ablation	8	11	46
NODE-301 Part 2 and Part 3 Test Dose failure	0	0	8
NODE-301 Part 2 and Part 3 Adverse Event	1	3	14
NODE-301 Part 2 and Part 3 Physician Decision	0	0	2
NODE-301 Part 2 and Part 3 Lost to Follow-up	1	0	7
NODE-301 Part 2 and Part 3 Protocol Violation	0	1	2
NODE-301 Part 2 and Part 3 Pregnancy	0	0	1
NODE-301 Part 2 and Part 3 Prohibited Medication	1	1	4
NODE-301 Part 2 and Part 3 Study Terminated by Sponsor	46	61	314
NODE-301 Part 2 and Part 3 Reason was not provided by the participant	5	1	15

Baseline Characteristics

Participants are included under their respective column.

Baseline characteristics by cohort

Measure	Part 1 - Placebo Single Dose n=60 Participants Self-administration of a single dose of placebo for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Etripamil 70 mg n=138 Participants Self-administration of a single dose of etripamil 70 mg for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Test Dose Only n=233 Participants Single Test Dose of etripamil 70 mg in sinus rhythm before randomization	Parts 2 and 3 - Placebo With Optional Second Dose of Placebo n=143 Participants Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted, during the randomized treatment period.	Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg n=160 Participants Self-administration of etripamil 70 mg for a perceived episode of PSVT followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted, during the randomized treatment period.	Parts 2 and 3 - Test Dose Only (2X70 mg) n=445 Participants Repeat Test Dose of etripamil 70 mg (2X70 mg) 10 minutes apart in sinus rhythm before randomization	Total n=1179 Participants Total of all reporting groups
Age, Continuous Part 1	55.0 years STANDARD_DEVIATION 14.96 • n=60 Participants • Participants are included under their respective column.	57.2 years STANDARD_DEVIATION 13.58 • n=138 Participants • Participants are included under their respective column.	54.1 years STANDARD_DEVIATION 15.59 • n=233 Participants • Participants are included under their respective column.	—	—	—	55.2 years STANDARD_DEVIATION 14.92 • n=431 Participants • Participants are included under their respective column.
Age, Continuous Parts 2 and 3	—	—	—	55.9 years STANDARD_DEVIATION 12.5 • n=143 Participants • Participants are included under their respective column.	52.2 years STANDARD_DEVIATION 13.9 • n=160 Participants • Participants are included under their respective column.	53.9 years STANDARD_DEVIATION 14.9 • n=445 Participants • Participants are included under their respective column.	53.9 years STANDARD_DEVIATION 14.1 • n=748 Participants • Participants are included under their respective column.
Age, Customized Part 1: Age at confirmation of PSVT (years)	53.8 years STANDARD_DEVIATION 15.03 • n=60 Participants • Participants are included under their respective column.	56.3 years STANDARD_DEVIATION 13.69 • n=138 Participants • Participants are included under their respective column.	53.2 years STANDARD_DEVIATION 15.72 • n=233 Participants • Participants are included under their respective column.	—	—	—	54.3 years STANDARD_DEVIATION 15.03 • n=431 Participants • Participants are included under their respective column.
Age, Customized Parts 2 and 3: Age at confirmation of PSVT (years)	—	—	—	54.9 years STANDARD_DEVIATION 12.9 • n=143 Participants • Participants are included under their respective column.	50.4 years STANDARD_DEVIATION 14.5 • n=160 Participants • Participants are included under their respective column.	52.5 years STANDARD_DEVIATION 14.6 • n=445 Participants • Participants are included under their respective column.	52.5 years STANDARD_DEVIATION 14.3 • n=748 Participants • Participants are included under their respective column.
Sex: Female, Male Part 1 · Female	39 Participants n=60 Participants • Participants are included under their respective column.	92 Participants n=138 Participants • Participants are included under their respective column.	142 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	273 Participants n=431 Participants • Participants are included under their respective column.
Sex: Female, Male Part 1 · Male	21 Participants n=60 Participants • Participants are included under their respective column.	46 Participants n=138 Participants • Participants are included under their respective column.	91 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	158 Participants n=431 Participants • Participants are included under their respective column.
Sex: Female, Male Parts 2 and 3 · Female	—	—	—	100 Participants n=143 Participants • Participants are included under their respective column.	112 Participants n=160 Participants • Participants are included under their respective column.	268 Participants n=445 Participants • Participants are included under their respective column.	480 Participants n=748 Participants • Participants are included under their respective column.
Sex: Female, Male Parts 2 and 3 · Male	—	—	—	43 Participants n=143 Participants • Participants are included under their respective column.	48 Participants n=160 Participants • Participants are included under their respective column.	177 Participants n=445 Participants • Participants are included under their respective column.	268 Participants n=748 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Part 1 · Hispanic or Latino	0 Participants n=60 Participants • Participants are included under their respective column.	5 Participants n=138 Participants • Participants are included under their respective column.	5 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	10 Participants n=431 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Part 1 · Not Hispanic or Latino	56 Participants n=60 Participants • Participants are included under their respective column.	129 Participants n=138 Participants • Participants are included under their respective column.	220 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	405 Participants n=431 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Part 1 · Unknown or Not Reported	4 Participants n=60 Participants • Participants are included under their respective column.	4 Participants n=138 Participants • Participants are included under their respective column.	8 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	16 Participants n=431 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Parts 2 and 3 · Hispanic or Latino	—	—	—	12 Participants n=143 Participants • Participants are included under their respective column.	11 Participants n=160 Participants • Participants are included under their respective column.	50 Participants n=445 Participants • Participants are included under their respective column.	73 Participants n=748 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Parts 2 and 3 · Not Hispanic or Latino	—	—	—	129 Participants n=143 Participants • Participants are included under their respective column.	147 Participants n=160 Participants • Participants are included under their respective column.	384 Participants n=445 Participants • Participants are included under their respective column.	660 Participants n=748 Participants • Participants are included under their respective column.
Ethnicity (NIH/OMB) Parts 2 and 3 · Unknown or Not Reported	—	—	—	2 Participants n=143 Participants • Participants are included under their respective column.	2 Participants n=160 Participants • Participants are included under their respective column.	11 Participants n=445 Participants • Participants are included under their respective column.	15 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · American Indian or Alaska Native	1 Participants n=60 Participants • Participants are included under their respective column.	0 Participants n=138 Participants • Participants are included under their respective column.	0 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	1 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · Asian	2 Participants n=60 Participants • Participants are included under their respective column.	5 Participants n=138 Participants • Participants are included under their respective column.	14 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	21 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants • Participants are included under their respective column.	2 Participants n=138 Participants • Participants are included under their respective column.	2 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	4 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · Black or African American	4 Participants n=60 Participants • Participants are included under their respective column.	6 Participants n=138 Participants • Participants are included under their respective column.	17 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	27 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · White	51 Participants n=60 Participants • Participants are included under their respective column.	120 Participants n=138 Participants • Participants are included under their respective column.	194 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	365 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · More than one race	0 Participants n=60 Participants • Participants are included under their respective column.	0 Participants n=138 Participants • Participants are included under their respective column.	0 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	0 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Part 1 · Unknown or Not Reported	2 Participants n=60 Participants • Participants are included under their respective column.	5 Participants n=138 Participants • Participants are included under their respective column.	6 Participants n=233 Participants • Participants are included under their respective column.	—	—	—	13 Participants n=431 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · American Indian or Alaska Native	—	—	—	0 Participants n=143 Participants • Participants are included under their respective column.	1 Participants n=160 Participants • Participants are included under their respective column.	0 Participants n=445 Participants • Participants are included under their respective column.	1 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · Asian	—	—	—	5 Participants n=143 Participants • Participants are included under their respective column.	2 Participants n=160 Participants • Participants are included under their respective column.	8 Participants n=445 Participants • Participants are included under their respective column.	15 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · Native Hawaiian or Other Pacific Islander	—	—	—	0 Participants n=143 Participants • Participants are included under their respective column.	0 Participants n=160 Participants • Participants are included under their respective column.	1 Participants n=445 Participants • Participants are included under their respective column.	1 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · Black or African American	—	—	—	3 Participants n=143 Participants • Participants are included under their respective column.	5 Participants n=160 Participants • Participants are included under their respective column.	17 Participants n=445 Participants • Participants are included under their respective column.	25 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · White	—	—	—	131 Participants n=143 Participants • Participants are included under their respective column.	149 Participants n=160 Participants • Participants are included under their respective column.	408 Participants n=445 Participants • Participants are included under their respective column.	688 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · More than one race	—	—	—	0 Participants n=143 Participants • Participants are included under their respective column.	0 Participants n=160 Participants • Participants are included under their respective column.	0 Participants n=445 Participants • Participants are included under their respective column.	0 Participants n=748 Participants • Participants are included under their respective column.
Race (NIH/OMB) Parts 2 and 3 · Unknown or Not Reported	—	—	—	4 Participants n=143 Participants • Participants are included under their respective column.	3 Participants n=160 Participants • Participants are included under their respective column.	11 Participants n=445 Participants • Participants are included under their respective column.	18 Participants n=748 Participants • Participants are included under their respective column.
PSVT confirmation duration (years) Part 1	1.7 years STANDARD_DEVIATION 4.45 • n=60 Participants • Participants are included under their respective column.	1.4 years STANDARD_DEVIATION 2.39 • n=138 Participants • Participants are included under their respective column.	1.4 years STANDARD_DEVIATION 2.39 • n=233 Participants • Participants are included under their respective column.	—	—	—	1.4 years STANDARD_DEVIATION 2.76 • n=431 Participants • Participants are included under their respective column.
PSVT confirmation duration (years) Parts 2 and 3	—	—	—	1.6 years STANDARD_DEVIATION 3.6 • n=143 Participants • Participants are included under their respective column.	2.3 years STANDARD_DEVIATION 5.2 • n=160 Participants • Participants are included under their respective column.	1.9 years STANDARD_DEVIATION 4.2 • n=445 Participants • Participants are included under their respective column.	1.9 years STANDARD_DEVIATION 4.3 • n=748 Participants • Participants are included under their respective column.
Number of participant reported PSVT episodes in the past year Part 1	12.5 episodes STANDARD_DEVIATION 17.91 • n=59 Participants • Information not available for some participants. Participants are included under their respective column.	7.8 episodes STANDARD_DEVIATION 7.65 • n=138 Participants • Information not available for some participants. Participants are included under their respective column.	6.6 episodes STANDARD_DEVIATION 13.11 • n=232 Participants • Information not available for some participants. Participants are included under their respective column.	—	—	—	7.8 episodes STANDARD_DEVIATION 12.60 • n=429 Participants • Information not available for some participants. Participants are included under their respective column.
Number of participant reported PSVT episodes in the past year Parts 2 and 3	—	—	—	10.0 episodes STANDARD_DEVIATION 21.1 • n=143 Participants • Information not available for some participants. Participants are included under their respective column.	6.8 episodes STANDARD_DEVIATION 15.1 • n=160 Participants • Information not available for some participants. Participants are included under their respective column.	5.7 episodes STANDARD_DEVIATION 11.3 • n=444 Participants • Information not available for some participants. Participants are included under their respective column.	6.7 episodes STANDARD_DEVIATION 14.5 • n=747 Participants • Information not available for some participants. Participants are included under their respective column.
Number of participant reported emergency department visits for PSVT in lifetime Part 1	5.0 emergency department visits STANDARD_DEVIATION 13.17 • n=59 Participants • Information not available for some participants. Participants are included under their respective column.	2.7 emergency department visits STANDARD_DEVIATION 3.69 • n=134 Participants • Information not available for some participants. Participants are included under their respective column.	2.4 emergency department visits STANDARD_DEVIATION 3.20 • n=230 Participants • Information not available for some participants. Participants are included under their respective column.	—	—	—	2.8 emergency department visits STANDARD_DEVIATION 5.87 • n=423 Participants • Information not available for some participants. Participants are included under their respective column.
Number of participant reported emergency department visits for PSVT in lifetime Parts 2 and 3	—	—	—	3.6 emergency department visits STANDARD_DEVIATION 10.3 • n=143 Participants • Information not available for some participants. Participants are included under their respective column.	4.3 emergency department visits STANDARD_DEVIATION 14.2 • n=160 Participants • Information not available for some participants. Participants are included under their respective column.	2.3 emergency department visits STANDARD_DEVIATION 5.3 • n=445 Participants • Information not available for some participants. Participants are included under their respective column.	3.0 emergency department visits STANDARD_DEVIATION 9.0 • n=748 Participants • Information not available for some participants. Participants are included under their respective column.
Participants with past ablation, n (%) Yes	—	—	—	11 Participants n=143 Participants • NODE-301 part 1 did not collect this information.	13 Participants n=160 Participants • NODE-301 part 1 did not collect this information.	24 Participants n=445 Participants • NODE-301 part 1 did not collect this information.	48 Participants n=748 Participants • NODE-301 part 1 did not collect this information.
Participants with past ablation, n (%) No	—	—	—	132 Participants n=143 Participants • NODE-301 part 1 did not collect this information.	147 Participants n=160 Participants • NODE-301 part 1 did not collect this information.	421 Participants n=445 Participants • NODE-301 part 1 did not collect this information.	700 Participants n=748 Participants • NODE-301 part 1 did not collect this information.
Weight Part 1	83.99 Kg STANDARD_DEVIATION 20.994 • n=60 Participants • Data not available for some participants. Participants are included under their respective column.	82.45 Kg STANDARD_DEVIATION 23.787 • n=138 Participants • Data not available for some participants. Participants are included under their respective column.	83.80 Kg STANDARD_DEVIATION 24.149 • n=230 Participants • Data not available for some participants. Participants are included under their respective column.	—	—	—	83.39 Kg STANDARD_DEVIATION 23.571 • n=428 Participants • Data not available for some participants. Participants are included under their respective column.
Weight Parts 2 and 3	—	—	—	82.7 Kg STANDARD_DEVIATION 19.4 • n=142 Participants • Data not available for some participants. Participants are included under their respective column.	81.1 Kg STANDARD_DEVIATION 19.9 • n=158 Participants • Data not available for some participants. Participants are included under their respective column.	81.4 Kg STANDARD_DEVIATION 19.3 • n=430 Participants • Data not available for some participants. Participants are included under their respective column.	81.6 Kg STANDARD_DEVIATION 19.4 • n=730 Participants • Data not available for some participants. Participants are included under their respective column.
Height Part 1	168.7 cm STANDARD_DEVIATION 9.12 • n=60 Participants • Data not available for some participants. Participants are included under their respective column.	168.8 cm STANDARD_DEVIATION 10.24 • n=138 Participants • Data not available for some participants. Participants are included under their respective column.	169.0 cm STANDARD_DEVIATION 9.70 • n=230 Participants • Data not available for some participants. Participants are included under their respective column.	—	—	—	169.0 cm STANDARD_DEVIATION 9.6 • n=428 Participants • Data not available for some participants. Participants are included under their respective column.
Height Parts 2 and 3	—	—	—	168.6 cm STANDARD_DEVIATION 9.4 • n=143 Participants • Data not available for some participants. Participants are included under their respective column.	168.7 cm STANDARD_DEVIATION 9.2 • n=159 Participants • Data not available for some participants. Participants are included under their respective column.	169.9 cm STANDARD_DEVIATION 10.2 • n=431 Participants • Data not available for some participants. Participants are included under their respective column.	169.4 cm STANDARD_DEVIATION 9.9 • n=733 Participants • Data not available for some participants. Participants are included under their respective column.

PRIMARY outcome

Timeframe: NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing.

Population: In NODE-301 Part 1, the efficacy population consisted of 156 participants (37.2% of the 419 randomized participants). In NODE-301 Parts 2 and 3, the efficacy population consisted of 214 participants (29.1% of the 735 randomized participants). The efficacy population was a modified intent-to-treat (mITT) population that included all participants who took study drug to treat an episode of perceived PSVT that was adjudicated by the Independent Adjudication Committee to be confirmed PSVT.

The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.

Outcome measures

Measure	Part 1 - Placebo Single Dose n=49 Participants Self-administration of a single dose of placebo for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Etripamil 70 mg n=107 Participants Self-administration of a single dose of etripamil 70 mg for a perceived episode of PSVT during the randomized treatment period.	Parts 2 and 3 - Placebo With Optional Second Dose of Placebo n=100 Participants Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted, during the randomized treatment period.	Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg n=114 Participants Self-administration of etripamil 70 mg for a perceived episode of PSVT followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted, during the randomized treatment period.
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. Part 1: Participants converted to sinus rhythm within 5 hours	36 Participants	80 Participants	—	—
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. Part 1: Participants censored	13 Participants	27 Participants	—	—
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. Parts 2 and 3: Participants converted to sinus rhythm within 30 minutes	—	—	30 Participants	75 Participants
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. Parts 2 and 3: Participants censored	—	—	70 Participants	39 Participants

Adverse Events

Part 1 - Placebo Single Dose

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Part 1 - Etripamil 70 mg

Serious events: 1 serious events

Other events: 98 other events

Deaths: 0 deaths

Part 1 - Test Dose Only

Serious events: 4 serious events

Other events: 151 other events

Deaths: 0 deaths

Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil

Serious events: 2 serious events

Other events: 127 other events

Deaths: 0 deaths

Parts 2 and 3 - Test Dose Only (2X70 mg)

Serious events: 18 serious events

Other events: 324 other events

Deaths: 1 deaths

Serious adverse events

Measure	Part 1 - Placebo Single Dose n=60 participants at risk Self-administration of a single dose of placebo for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Etripamil 70 mg n=138 participants at risk Self-administration of a single dose of etripamil 70 mg for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Test Dose Only n=233 participants at risk Single Test Dose of etripamil 70 mg in sinus rhythm before randomization.	Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil n=143 participants at risk Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted, during the randomized treatment period. AEs which occur after open-label etripamil treatment are included in this column.	Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil n=160 participants at risk Self-administration of etripamil 70 mg for a perceived episode of PSVT followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted, during the randomized treatment period. AEs which occur after open-label etripamil treatment are included in this column.	Parts 2 and 3 - Test Dose Only (2X70 mg) n=445 participants at risk Repeat Test Dose of etripamil 70 mg (2X70 mg) 10 minutes apart in sinus rhythm before randomization
Cardiac disorders Acute myocardial infarction	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.70% 1/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Cardiac disorders Supraventricular tachycardia	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.62% 1/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Cardiac disorders Cardiac arrest	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Gastrointestinal disorders Faecaloma	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.45% 2/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
General disorders Chest pain	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
General disorders Non-cardiac chest pain	1.7% 1/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Infections and infestations Corona virus infection	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.62% 1/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Infections and infestations Cellulitis	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.45% 2/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.67% 3/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.70% 1/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Renal and urinary disorders Acute kidney injury	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.70% 1/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Vascular disorders Deep vein thrombosis	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Eye disorders Retinal artery occlusion	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.72% 1/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Infections and infestations Sepsis	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.

Other adverse events

Measure	Part 1 - Placebo Single Dose n=60 participants at risk Self-administration of a single dose of placebo for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Etripamil 70 mg n=138 participants at risk Self-administration of a single dose of etripamil 70 mg for a perceived episode of PSVT during the randomized treatment period.	Part 1 - Test Dose Only n=233 participants at risk Single Test Dose of etripamil 70 mg in sinus rhythm before randomization.	Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil n=143 participants at risk Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted, during the randomized treatment period. AEs which occur after open-label etripamil treatment are included in this column.	Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil n=160 participants at risk Self-administration of etripamil 70 mg for a perceived episode of PSVT followed 10 minutes later by an optional second dose of etripamil 70 mg, if symptoms persisted, during the randomized treatment period. AEs which occur after open-label etripamil treatment are included in this column.	Parts 2 and 3 - Test Dose Only (2X70 mg) n=445 participants at risk Repeat Test Dose of etripamil 70 mg (2X70 mg) 10 minutes apart in sinus rhythm before randomization
Cardiac disorders Supraventricular tachycardia	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	7.7% 11/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	3.1% 5/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	1.8% 8/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Cardiac disorders Atrial fibrillation	6.7% 4/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.43% 1/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.70% 1/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	1.2% 2/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.22% 1/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Eye disorders Lacrimation increased	15.0% 9/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	5.8% 8/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	10.3% 24/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	19.6% 28/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	18.8% 30/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	16.6% 74/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Infections and infestations Corona virus infection	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	4.2% 6/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.9% 11/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	7.9% 35/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Nervous system disorders Headache	1.7% 1/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.0% 11/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	4.7% 11/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.3% 9/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.1% 13/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.5% 38/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Nervous system disorders Dizziness	3.3% 2/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	3.6% 5/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	5.6% 13/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	2.1% 3/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	3.1% 5/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	5.2% 23/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Nervous system disorders Dysgeusia	5.0% 3/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	5.8% 8/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	4.3% 10/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	3.5% 5/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.2% 10/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	2.7% 12/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	25.0% 15/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	39.9% 55/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	42.1% 98/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	40.6% 58/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	43.8% 70/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	31.2% 139/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.3% 8/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	17.4% 24/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	11.2% 26/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	21.7% 31/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	26.2% 42/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	17.3% 77/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.3% 8/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	16.7% 23/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	12.4% 29/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	21.0% 30/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	26.2% 42/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	13.3% 59/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Throat irritation	5.0% 3/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	16.7% 23/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.6% 20/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	14.7% 21/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	19.4% 31/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	12.1% 54/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Sneezing	6.7% 4/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.0% 11/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	4.3% 10/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	9.8% 14/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	11.9% 19/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	8.5% 38/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.7% 1/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	11.6% 16/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	5.6% 13/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	9.8% 14/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	11.2% 18/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.1% 27/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 0/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.72% 1/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	0.00% 0/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.3% 9/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	3.1% 5/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.1% 27/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 3/60 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	1.4% 2/138 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	1.3% 3/233 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	2.8% 4/143 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	6.2% 10/160 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.	1.3% 6/445 • Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit). Adverse events were recorded based on the descriptions provided by the participants at every study visit. Adverse events are reported by participants group. For Parts 2 and 3, AEs which occurred after open-label etripamil treatment are included in the columns for placebo and etripamil for completeness.

Additional Information

Cameron Szakacs_PhD_VP Drug Development

Milestone Pharmaceuticals Inc.

Phone: 1 704-594-4102

Email: cszakacs@milestonepharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place