Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease (NCT NCT02114203)

NCT ID: NCT02114203

Last Updated: 2017-12-14

Results Overview

Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) \>=20 mmHg; (3) maximum decrease from baseline in supine SBP \>=30 mmHg; and (4) maximum decrease from baseline in supine DBP \>=20 mmHg.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline up to 30 days post last dose on Day 29
• Results posted on: 2017-12-14

Participant Flow

Overall, a total of 30 potential participants were randomized to the study, and 29 of them were assigned to and received study treatment, 1 participant in the PF-04447943 25 mg twice daily (BID) treatment group withdrew from the study after randomization but prior to study treatment.

Participant milestones

Measure	PF-04447943 5 mg BID PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Study STARTED	7	16	7
Overall Study COMPLETED	7	14	7
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Measure	PF-04447943 5 mg BID PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease

Baseline characteristics by cohort

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=16 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.	Total n=30 Participants Total of all reporting groups
Age, Continuous	37.9 years STANDARD_DEVIATION 10.6 • n=93 Participants	36.3 years STANDARD_DEVIATION 11.0 • n=4 Participants	39.4 years STANDARD_DEVIATION 14.0 • n=27 Participants	37.4 years STANDARD_DEVIATION 11.3 • n=483 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	10 Participants n=4 Participants	5 Participants n=27 Participants	18 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	12 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg; (3) maximum decrease from baseline in supine SBP >=30 mmHg; and (4) maximum decrease from baseline in supine DBP >=20 mmHg.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs Maximum increase in supine SBP >=30 mmHg	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs Maximum increase in supine DBP >=20 mmHg	2 participants	0 participants	1 participants
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs Maximum decrease in supine SBP >=30 mmHg	0 participants	1 participants	0 participants
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs Maximum decrease in supine DBP >=20 mmHg	2 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: Baseline up to Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

Clinical assessment of neurologic functions included cranial nerve function, coordination, deep tendon reflexes, muscle strength, and reflexes (left and right ankles). Clinical importance of neurologic function changes was determined by the investigator.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical importance of physical examination changes was determined by the investigator.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS complex percent increase from baseline >=25/50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Maximum PR interval >=300 msec	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Maximum QRS complex >=200 msec	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Maximum QTcF interval: 450 to <480 msec	0 participants	3 participants	2 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Maximum QTcF interval: 480 to <500 msec	0 participants	0 participants	1 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings Maximum QTcF interval: >=500 msec	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings PR interval increase >=25/50 percent	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings QRS complex increase >=25/50 percent	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings QTcF interval increase: 30 to <60 msec	0 participants	1 participants	0 participants
Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings QTcF interval increase >=60 msec	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

The following symptoms were assessed: anemia; fatigue; chronic pain; acute pain; infections; fever; swelling hands; swelling feet; abdominal swelling; pale skin; pale nail beds; yellow tint to skin; whites of eyes turned yellow; stroke. Number of participants with changes from baseline deemed potentially clinically important by the investigator is presented.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 1 to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to follow-up visit (30 days post last dose on Day 29) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) AEs	7 participants	13 participants	7 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	2 participants	1 participants	0 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Withdrawal due to TEAEs	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post last dose on Day 29

Population: The safety analysis population was defined as all participants who received at least 1 dose of study medication.

The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, serum creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and high sensitivity C-reactive protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone and serum human chorionic gonadotropin, urine drug screening). Abnormality was determined by the investigator.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 Participants Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Number of Participants With Laboratory Test Abnormalities	7 participants	15 participants	7 participants

SECONDARY outcome

Timeframe: Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1

Population: The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.

AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943	242.0 nanogram*hour/milliliter Geometric Coefficient of Variation 35	1170 nanogram*hour/milliliter Geometric Coefficient of Variation 29	—

SECONDARY outcome

Timeframe: Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1

Population: The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Maximum Observed Plasma Concentration (Cmax) of PF-04447943	45.83 ng/mL Geometric Coefficient of Variation 39	248.2 ng/mL Geometric Coefficient of Variation 31	—

SECONDARY outcome

Timeframe: Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1

Population: The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.

Outcome measures

Measure	PF-04447943 5 mg BID n=7 Participants PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 Participants PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943	1.92 hours Interval 1.0 to 4.0	1.00 hours Interval 0.5 to 4.05	—

Adverse Events

PF-04447943 5 mg BID

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-04447943 25 mg BID

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-04447943 5 mg BID n=7 participants at risk PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 participants at risk PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 participants at risk Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Biliary colic	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Measure	PF-04447943 5 mg BID n=7 participants at risk PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.	PF-04447943 25 mg BID n=15 participants at risk PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.	Placebo n=7 participants at risk Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Congenital, familial and genetic disorders Sickle cell anaemia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Ocular icterus	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal distension	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain upper	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Constipation	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dyspepsia	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Chest discomfort	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	40.0% 6/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Gait disturbance	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pain	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Peripheral swelling	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pyrexia	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Tenderness	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Jaundice	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Immune system disorders Seasonal allergy	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Nasopharyngitis	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Rhinitis	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Laceration	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Blood pressure systolic increased	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Neutrophil count decreased	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Urine analysis abnormal	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	20.0% 3/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	57.1% 4/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 5/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Lethargy	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Migraine	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Poor quality sleep	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Somnolence	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Insomnia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Chromaturia	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Priapism	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	6.7% 1/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Pallor	0.00% 0/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	13.3% 2/15 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Day 1 to follow-up visit (30 days post last dose on Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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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