Trial Outcomes & Findings for 2-Week Study In People With Nonalcoholic Fatty Liver Disease (NCT NCT03513588)

NCT ID: NCT03513588

Last Updated: 2020-03-13

Results Overview

MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline (Day 1), Day 15
• Results posted on: 2020-03-13

Participant Flow

Participant milestones

Measure	Placebo Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Overall Study STARTED	16	17	15
Overall Study COMPLETED	15	15	13
Overall Study NOT COMPLETED	1	2	2

Reasons for withdrawal

Measure	Placebo Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Overall Study Lost to Follow-up	0	1	1
Overall Study Study dosing paused by sponsor	1	1	0
Overall Study Death	0	0	1

Baseline Characteristics

2-Week Study In People With Nonalcoholic Fatty Liver Disease

Baseline characteristics by cohort

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.	Total n=48 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 10.5 • n=93 Participants	47.0 years STANDARD_DEVIATION 8.0 • n=4 Participants	48.3 years STANDARD_DEVIATION 5.5 • n=27 Participants	47.0 years STANDARD_DEVIATION 8.2 • n=483 Participants
Age, Customized 18-44 years	7 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	14 Participants n=483 Participants
Age, Customized 45-64 years	9 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	34 Participants n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	35 Participants n=483 Participants
Race/Ethnicity, Customized White	13 Participants n=93 Participants	14 Participants n=4 Participants	9 Participants n=27 Participants	36 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	9 Participants n=483 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 15

Population: All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo) and had whole liver fat assessed at Day 15.

MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

Outcome measures

Measure	Placebo n=15 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)	-10.94 percentage of whole liver fat Interval -16.65 to -4.83	-32.62 percentage of whole liver fat Interval -37.02 to -27.9	-41.14 percentage of whole liver fat Interval -44.91 to -37.12

SECONDARY outcome

Timeframe: From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)

Population: All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	2 Participants	12 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)

Population: All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Number of Participants With Laboratory Test Abnormalities	5 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)

Population: All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).

Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP >=30 mmHg.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Number of Participants With Vital Sign Abnormalities Supine SBP <90 mm Hg	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Supine SBP increase >=30 mm Hg	2 Participants	1 Participants	2 Participants
Number of Participants With Vital Sign Abnormalities Supine SBP decrease >=30 mm Hg	1 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Pulse rate <40 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Pulse rate >120 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Supine DBP <50 mmHg	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Supine DBP increase >=20 mm Hg	2 Participants	0 Participants	3 Participants
Number of Participants With Vital Sign Abnormalities Supine DBP decrease >=20 mm Hg	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)

Population: All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).

ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (heart rate corrected QT [time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle] using Fridericia's formula): absolute value of >450 to 480 msec, >480 to 500 msec, >500 msec; a change from baseline of >30 to 60 msec or >60 msec.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 Participants Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Number of Participants With Electrocardiogram (ECG) Abnormalities %Change in PR interval >=25/50%	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QRS interval >=140 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF >450 to <=480 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF >480 to <=500 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF >500 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF change >30 to <=60 msec	0 Participants	1 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities PR interval >=300 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities %Change in QRS interval >=50%	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF change >60 msec	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax data.

Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Maximum Plasma Concentration (Cmax) For PF-06865571	345.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35	2001 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28	—

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had AUCtau data.

AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages.

Outcome measures

Measure	Placebo n=15 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571	1036 nanograms*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 35	7798 nanograms*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 26	—

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Tmax data.

Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence.

Outcome measures

Measure	Placebo n=16 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmin data.

Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.

Outcome measures

Measure	Placebo n=15 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Minimum Plasma Concentration (Cmin) For PF-06865571	6.609 ng/mL Geometric Coefficient of Variation 75	57.79 ng/mL Geometric Coefficient of Variation 68	—

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had CL/F data.

CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages.

Outcome measures

Measure	Placebo n=15 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Apparent Oral Clearance (CL/F) For PF-06865571	48.30 liters per hour (L/hr) Geometric Coefficient of Variation 35	38.49 liters per hour (L/hr) Geometric Coefficient of Variation 26	—

SECONDARY outcome

Timeframe: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax and non-zero Cmin data for PTR evaluation.

PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages.

Outcome measures

Measure	Placebo n=14 Participants Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=15 Participants Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Peak-to-Trough Ratio (PTR) For PF-06865571	53.17 ratio of concentrations Geometric Coefficient of Variation 68	34.63 ratio of concentrations Geometric Coefficient of Variation 75	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-06865571 50 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

PF-06865571 300 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo n=16 participants at risk Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 participants at risk Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 participants at risk Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Measure	Placebo n=16 participants at risk Participants received matching placebo tablets orally every 12 hours (Q12H) for 14 days.	PF-06865571 50 mg n=17 participants at risk Participants received PF-06865571 50 mg tablets orally Q12H for 14 days.	PF-06865571 300 mg n=15 participants at risk Participants received PF-06865571 300 mg tablets orally Q12H for 14 days.
General disorders Fatigue	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Constipation	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	11.8% 2/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	35.3% 6/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Micturition urgency	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Pollakiuria	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye pruritus	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal distension	6.2% 1/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	11.8% 2/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Flatulence	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Blood pressure increased	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	17.6% 3/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Nervousness	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Dysuria	6.2% 1/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.2% 1/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	5.9% 1/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Flushing	0.00% 0/16 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/17 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days) The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Additional Information

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Phone: 1-800-718-1021

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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