Trial Outcomes & Findings for An 8-Week Refractory Chronic Cough Study (MK-7264-021) (NCT NCT02612623)

Last Updated: 2019-11-25

Results Overview

Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Baseline and Week 8 (Day 56)

Results posted on

2019-11-25

Participant Flow

Male and female participants with treatment-refractory chronic cough were enrolled in this study.

Participant milestones

Participant milestones
Measure	Gefapixant 15 mg Twice Daily Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg Twice Daily Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg Twice Daily One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks	Placebo to Match Gefapixant Matching placebo tablets administered by mouth twice daily for 8 weeks
Overall Study STARTED	8	6	6	4
Overall Study Treated	8	5	6	4
Overall Study COMPLETED	7	5	5	4
Overall Study NOT COMPLETED	1	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefapixant 15 mg Twice Daily Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg Twice Daily Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg Twice Daily One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks	Placebo to Match Gefapixant Matching placebo tablets administered by mouth twice daily for 8 weeks
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Adverse Event	1	0	1	0

Baseline Characteristics

All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefapixant 15 mg Twice Daily n=8 Participants Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg Twice Daily n=5 Participants Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg Twice Daily n=6 Participants One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks	Placebo to Match Gefapixant n=4 Participants Matching placebo tablets administered by mouth twice daily for 8 weeks	Total n=23 Participants Total of all reporting groups
Age, Continuous	60.30 Years STANDARD_DEVIATION 10.39 • n=8 Participants	66.60 Years STANDARD_DEVIATION 7.30 • n=5 Participants	62.70 Years STANDARD_DEVIATION 11.04 • n=6 Participants	63.50 Years STANDARD_DEVIATION 2.38 • n=4 Participants	62.80 Years STANDARD_DEVIATION 8.85 • n=23 Participants
Sex: Female, Male Female	8 Participants n=8 Participants	4 Participants n=5 Participants	5 Participants n=6 Participants	3 Participants n=4 Participants	20 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	1 Participants n=5 Participants	1 Participants n=6 Participants	1 Participants n=4 Participants	3 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	1 Participants n=4 Participants	1 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=8 Participants	5 Participants n=5 Participants	6 Participants n=6 Participants	3 Participants n=4 Participants	22 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=5 Participants	1 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Race (NIH/OMB) White	8 Participants n=8 Participants	5 Participants n=5 Participants	5 Participants n=6 Participants	4 Participants n=4 Participants	22 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=23 Participants
Cough Frequency	57.6 Coughs/hour STANDARD_DEVIATION 35.98 • n=7 Participants • All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.	42.7 Coughs/hour STANDARD_DEVIATION 21.22 • n=5 Participants • All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.	41.0 Coughs/hour STANDARD_DEVIATION 29.98 • n=5 Participants • All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.	60.4 Coughs/hour STANDARD_DEVIATION 38.84 • n=4 Participants • All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.	50.6 Coughs/hour STANDARD_DEVIATION 30.98 • n=21 Participants • All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.

PRIMARY outcome

Timeframe: Baseline and Week 8 (Day 56)

Population: All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg Twice Daily n=7 Participants Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg Twice Daily n=5 Participants Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg Twice Daily n=5 Participants One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks	Placebo to Match Gefapixant n=4 Participants Matching placebo tablets administered by mouth twice daily for 8 weeks
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.	-7.5 Coughs/hour Standard Deviation 40.58	-16.9 Coughs/hour Standard Deviation 13.68	-18.5 Coughs/hour Standard Deviation 26.88	0.3 Coughs/hour Standard Deviation 24.96

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Gefapixant 15 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Gefapixant 30 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Gefapixant 50 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=4 participants at risk Matching placebo tablets administered by mouth twice daily for 8 weeks	Gefapixant 15 mg n=8 participants at risk Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg n=5 participants at risk Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg n=6 participants at risk One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Nervous system disorders Syncope	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results obtained during the course of this study will be kept confidential and will not be disclosed in whole or in part to others or used for any purpose other than reviewing or performing the study without the written consent of the Sponsor. No data collected as part of this study will be utilized in any written work, including publications, without the written consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=4 participants at risk Matching placebo tablets administered by mouth twice daily for 8 weeks	Gefapixant 15 mg n=8 participants at risk Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 30 mg n=5 participants at risk Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks	Gefapixant 50 mg n=6 participants at risk One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
General disorders Inflammation	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Infections and infestations Tinea pedis	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	16.7% 1/6 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	40.0% 2/5 • Number of events 2 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	66.7% 4/6 • Number of events 5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Nervous system disorders Hypogeusia	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	33.3% 2/6 • Number of events 2 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Nervous system disorders Presyncope	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	25.0% 1/4 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/5 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/4 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/8 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	20.0% 1/5 • Number of events 1 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.	0.00% 0/6 • Up to 14 days after Day 57 (up to 71 days) The population analyzed was all randomized participants who had received at least 1 dose of study drug.