Trial Outcomes & Findings for Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen (NCT NCT04346615)

Last Updated: 2024-05-02

Results Overview

The 6POSRS score was used to assess severity and ranged from 1 to 6 where: 1= Death; 2= Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, not requiring supplemental oxygen and 6= not hospitalized. A higher score indicated a better outcome.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

47 participants

Primary outcome timeframe

Day 15

Results posted on

2024-05-02

Participant Flow

A total of 47 participants signed the informed consent form and were enrolled in the study, of which 3 participants failed screening and 44 participants were randomized in the study. The study was terminated early because of lack of enrollment due to the evolution of the COVID-19 pandemic, with a reduction of participants at risk for severe disease, and a growing number of effective alternative therapies.

Participant milestones

Participant milestones
Measure	Zavegepant Participants were randomized to receive 10 milligrams (mg) of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Overall Study STARTED	29	15
Overall Study COMPLETED	22	10
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Zavegepant Participants were randomized to receive 10 milligrams (mg) of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Death	5	1
Overall Study Other	0	2
Overall Study Randomized not treated	1	0

Baseline Characteristics

Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Total n=43 Participants Total of all reporting groups
Age, Continuous	53.0 Years STANDARD_DEVIATION 13.42 • n=5 Participants	61.1 Years STANDARD_DEVIATION 12.41 • n=7 Participants	55.8 Years STANDARD_DEVIATION 13.49 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Zavegepant n=20 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=11 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Mean 6 Point Ordinal Severity Rating Scale (6POSRS) Score at Day 15	5.0 Units on a scale Standard Deviation 1.81	4.5 Units on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Day 29

Population: Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug.

Percentage of participants who were alive and had a 6POSRS rating of 5 (Hospitalized, not requiring supplemental oxygen) or 6 (not hospitalized) and did not use supplemental oxygen at Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had the last on-study 6POSRS rating before Day 29 used. Participants with \>= 1 procedure day of supplemental oxygen use before Day 29 for an ongoing procedure were considered failures, i.e., not alive or not off of oxygen at Day 29. 95% confidence interval (CI) was based on exact Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Percentage of Participants With a 6-Point Severity Rating of 5 or 6, Who Were Alive and Off Supplemental Oxygen at Day 29	67.9 Percentage of participants Interval 47.7 to 84.1	60.0 Percentage of participants Interval 32.3 to 83.7

SECONDARY outcome

Timeframe: Up to Day 29

Population: Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug.

Percentage of participants who had a 6POSRS rating of 2 (Hospitalized, on invasive mechanical ventilation or ECMO) or 3 (Hospitalized, on non-invasive ventilation or high-flow oxygen devices) or \>= 1 procedure day of ventilation or high-flow nasal cannula use on study through Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had all available on-study 6POSRS ratings before Day 29 used. 95% CI was based on exact Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Percentage of Participants With a 6-Point Severity Rating of 2 or 3 or Required Initiation of Invasive Mechanical Ventilation, Non-Invasive Ventilation, or a High-Flow Nasal Cannula Through Day 29	46.4 Percentage of participants Interval 27.5 to 66.1	60.0 Percentage of participants Interval 32.3 to 83.7

SECONDARY outcome

Timeframe: Up to Day 29

Population: Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug.

Percentage of participants admitted into an ICU on any day through Day 29 were reported in this outcome measure. 95% CI was based on exact Clopper and Pearson method

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Percentage of Participants Admitted Into an Intensive Care Unit (ICU) Through Day 29	25.0 Percentage of participants Interval 10.7 to 44.9	20.0 Percentage of participants Interval 4.3 to 48.1

SECONDARY outcome

Timeframe: From first dose of study treatment on Day 1 until Day 15

Population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo).

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important medical events. Severe AEs were AEs that interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. On-treatment was defined as the time on study drug.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs) Death	1 Participants	1 Participants
Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs) SAEs	6 Participants	2 Participants
Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs) Severe AEs	7 Participants	3 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment on Day 1 until Day 15

Population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes, lymphocytes (high and low), neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium (high and low), creatine kinase, creatinine, glomerular filtration rate (GFR) estimated Modification of Diet in Renal Disease (MDRD), glucose (high and low), lactate dehydrogenase, potassium (high and low), sodium (high and low), urate, glucose (urine) and protein (urine). Laboratory abnormalities were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 for all parameters except glucose and uric acid. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 was used for grading glucose and uric acid. Grade 3=severe and grade 4=potentially life threatening. Number of participants with grade 3 or 4 laboratory abnormalities is reported.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Eosinophils	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Hemoglobin	2 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Leukocytes	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Lymphocytes, high	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Lymphocytes, low	3 Participants	3 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Neutrophils	0 Participants	1 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Platelets	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Alanine Aminotransferase	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Albumin	1 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Alkaline Phosphatase	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Aspartate Aminotransferase	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Bicarbonate	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Bilirubin	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Calcium, high	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Calcium, low	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Glomerular Filtration Rate, Estimated MDRD	1 Participants	1 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Glucose, low	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Lactate Dehydrogenase	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Potassium, high	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Potassium, low	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Sodium, high	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Sodium, low	1 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Urate	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Creatine Kinase	1 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Creatinine	1 Participants	1 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Glucose, high	5 Participants	2 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Glucose, Urine	0 Participants	0 Participants
Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities Protein, Urine	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo).

Number of participants with any severe or life-threatening bacterial, invasive fungal, or opportunistic infections through Day 29 is reported in this outcome measure. Severe= interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Life threatening=Participant was at immediate risk of death from the event as it occurred; i.e., it did not include a reaction that if it had occurred in a more serious form might have caused death.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Number of Participants With Severe or Life-Threatening Bacterial, Invasive Fungal, or Opportunistic Infections Through Day 29	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo).

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=15 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Number of Participants With Intranasal Administration Reactions Through Day 29	16 Participants	3 Participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Day 15

Population: Safety analysis set included all participants who received \>=1 dose of study drug (zavegapant or placebo). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage of participants with \>=50% reduction in eGFR from Baseline during on-treatment phase were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Zavegepant n=28 Participants Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.	Placebo n=14 Participants Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
Percentage of Participants With >= 50% Reduction in Estimated Glomerular Filtration Rate (eGFR) From Baseline	7.1 Percentage of participants	14.3 Percentage of participants

Adverse Events

Zavegepant (On-treatment)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 1 deaths

Placebo (On-treatment)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 1 deaths

Zavegepant (Follow-up)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Placebo (Follow-up)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Zavegepant (On-treatment) n=28 participants at risk Participants received 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase.	Placebo (On-treatment) n=15 participants at risk Participants received placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase.	Zavegepant (Follow-up) n=27 participants at risk Participants who received zavegepant during the double-blind treatment phase were followed up from Day 16 to Day 60.	Placebo (Follow-up) n=13 participants at risk Participants who received placebo during the double-blind treatment phase were Followed up from Day 16 to Day 60.
Surgical and medical procedures Endotracheal intubation	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures Intensive care	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures Gastrostomy tube removal	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations Abdominal abscess	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations Pneumonia bacterial	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	7.7% 1/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations Sepsis	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations Alanine aminotransferase increased	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Renal and urinary disorders Acute kidney injury	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	3.7% 1/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders Haematoma	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations Bacteraemia	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	3.7% 1/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations Pneumonia	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	3.7% 1/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders Brain injury	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	3.7% 1/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	7.7% 1/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Other adverse events
Measure	Zavegepant (On-treatment) n=28 participants at risk Participants received 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase.	Placebo (On-treatment) n=15 participants at risk Participants received placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase.	Zavegepant (Follow-up) n=27 participants at risk Participants who received zavegepant during the double-blind treatment phase were followed up from Day 16 to Day 60.	Placebo (Follow-up) n=13 participants at risk Participants who received placebo during the double-blind treatment phase were Followed up from Day 16 to Day 60.
Nervous system disorders Dysgeusia	57.1% 16/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders Headache	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders Leukocytosis	28.6% 8/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	20.0% 3/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders Anaemia	14.3% 4/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	20.0% 3/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	3.7% 1/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	7.7% 1/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders Thrombocytosis	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders Polycythaemia	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hyperkalaemia	17.9% 5/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hyponatraemia	14.3% 4/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	33.3% 5/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hypermagnesaemia	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hypocalcaemia	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Gout	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders Hypokalaemia	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	15.4% 2/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	26.7% 4/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Aspiration	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Hypercapnia	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures Intensive care	14.3% 4/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	20.0% 3/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders Pyrexia	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	7.4% 2/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders Generalised oedema	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Hepatobiliary disorders Hepatitis	10.7% 3/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders Hypertension	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders Hypotension	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	7.4% 2/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders Flushing	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders Orthostatic hypotension	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders Constipation	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders Diarrhoea	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations Fibrin D dimer increased	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations Transaminases increased	3.6% 1/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	13.3% 2/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations Glomerular filtration rate decreased	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations Liver function test abnormal	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Psychiatric disorders Insomnia	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Psychiatric disorders Anxiety	0.00% 0/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Renal and urinary disorders Polyuria	7.1% 2/28 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	6.7% 1/15 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/27 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.	0.00% 0/13 • On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60 Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.