Trial Outcomes & Findings for The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012) (NCT NCT02336555)

Last Updated: 2019-12-09

Results Overview

Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS), in the morning prior to taking study treatment at Baseline (Day 1) in each treatment period, and then daily up to Day 28 in each treatment period. The NRS assesses the intensity of Post-herpetic Neuralgia (PHN) pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). The mean score in pain intensity of Week 4 (Days 22 to 28) minus the mean score at Baseline is presented, with a negative change representing improvement (or reduction) in pain intensity. In comparison to placebo, a reduction (difference in the change from Baseline) of 1 on the 11-point NRS is expected.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)

Results posted on

2019-12-09

Participant Flow

Males and females with post-herpetic neuralgia (PHN) with allodynia, at least 18 years of age (inclusive) were enrolled in this study.

Participant milestones

Participant milestones
Measure	MK-8291 → Placebo In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)	Placebo → MK-8291 In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
Treatment Period 1 (28 Days) STARTED	18	17
Treatment Period 1 (28 Days) COMPLETED	16	16
Treatment Period 1 (28 Days) NOT COMPLETED	2	1
Treatment Period 2 (28 Days) STARTED	16	16
Treatment Period 2 (28 Days) COMPLETED	16	15
Treatment Period 2 (28 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-8291 → Placebo In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)	Placebo → MK-8291 In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
Treatment Period 1 (28 Days) Withdrawal by Subject	0	1
Treatment Period 1 (28 Days) Physician Decision	2	0
Treatment Period 2 (28 Days) Adverse Event	0	1

Baseline Characteristics

Two MK-8291→Placebo and one Placebo→MK-8291 participants did not have Baseline NRS Pain Intensity Scale scores.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8291 → Placebo n=18 Participants In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)	Placebo → MK-8291 n=17 Participants In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)	Total n=35 Participants Total of all reporting groups
Age, Continuous	56.7 Years STANDARD_DEVIATION 16.7 • n=18 Participants	54.7 Years STANDARD_DEVIATION 13.5 • n=17 Participants	55.7 Years STANDARD_DEVIATION 15.0 • n=35 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	14 Participants n=17 Participants	25 Participants n=35 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	3 Participants n=17 Participants	10 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=18 Participants	17 Participants n=17 Participants	35 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) White	18 Participants n=18 Participants	17 Participants n=17 Participants	35 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Numerical Rating Scale (NRS) Pain Intesity Score at Baseline	6.63 Score on a scale STANDARD_DEVIATION 1.02 • n=16 Participants • Two MK-8291→Placebo and one Placebo→MK-8291 participants did not have Baseline NRS Pain Intensity Scale scores.	6.00 Score on a scale STANDARD_DEVIATION 0.97 • n=16 Participants • Two MK-8291→Placebo and one Placebo→MK-8291 participants did not have Baseline NRS Pain Intensity Scale scores.	6.31 Score on a scale STANDARD_DEVIATION 1.03 • n=32 Participants • Two MK-8291→Placebo and one Placebo→MK-8291 participants did not have Baseline NRS Pain Intensity Scale scores.

PRIMARY outcome

Timeframe: Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)

Population: The population consisted of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.

Outcome measures

Outcome measures
Measure	MK-8291 n=30 Participants Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)	Placebo n=32 Participants Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period	-1.776 Score on a scale Interval -2.442 to -1.11	-1.263 Score on a scale Interval -1.742 to -0.785

SECONDARY outcome

Timeframe: Baseline and Day 28 in each treatment period (Up to approximately 63 days)

Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS) in the morning before taking study treatment at Baseline (Day 1) in each treatment period, and then daily from Day 1 up to Day 28 in each treatment period. The NRS assesses the intensity of PHN pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). This was a binary outcome denoting whether the participant reported a percent change from Baseline to Week 4 (Days 22 to 28) in the mean pain intensity score greater than 30%. The percentage of participants who reported a 30% or greater change from Baseline to Day 28 of each treatment period is presented.

Outcome measures

Outcome measures
Measure	MK-8291 n=30 Participants Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)	Placebo n=32 Participants Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity	36.7 Percentage of participants Interval 19.9 to 56.1	34.4 Percentage of participants Interval 18.6 to 53.2

Adverse Events

MK-8291

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-8291 n=34 participants at risk Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)	Placebo n=33 participants at risk Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.

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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-8291 n=34 participants at risk Participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)	Placebo n=33 participants at risk Participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of a treatment period. (Up to 28 days in each treatment period)
Blood and lymphatic system disorders PANCYTOPENIA	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Ear and labyrinth disorders VERTIGO	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Eye disorders PHOTOPSIA	20.6% 7/34 • Number of events 7 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Eye disorders VISION BLURRED	8.8% 3/34 • Number of events 5 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Gastrointestinal disorders DRY MOUTH	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Gastrointestinal disorders NAUSEA	14.7% 5/34 • Number of events 10 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Gastrointestinal disorders VOMITING	14.7% 5/34 • Number of events 8 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
General disorders ASTHENIA	8.8% 3/34 • Number of events 4 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
General disorders CHILLS	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Infections and infestations CONJUNCTIVITIS	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Infections and infestations CYSTITIS	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Infections and infestations NASOPHARYNGITIS	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Infections and infestations PERIODONTITIS	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications FOOT FRACTURE	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/34 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders BALANCE DISORDER	8.8% 3/34 • Number of events 3 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders BURNING SENSATION	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders DIZZINESS	38.2% 13/34 • Number of events 25 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders DYSGEUSIA	2.9% 1/34 • Number of events 3 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders HEADACHE	5.9% 2/34 • Number of events 3 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	6.1% 2/33 • Number of events 2 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Nervous system disorders SOMNOLENCE	5.9% 2/34 • Number of events 2 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	3.0% 1/33 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders PRURITUS	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	2.9% 1/34 • Number of events 1 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.	0.00% 0/33 • From first dose of study treatment up to 14 days after last dose of study treatment (Up to a total of approximately 80 days) All-Cause Mortality Population: All randomized participants. Adverse Events Population: All participants who received at least one dose of study treatment.