Trial Outcomes & Findings for A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation (NCT NCT02156076)

Last Updated: 2019-07-31

Results Overview

AFB is defined as the percent of time spent in atrial fibrillation (AF). AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system. This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days. The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

158 participants

Primary outcome timeframe

Day 8 to Day 29

Results posted on

2019-07-31

Participant Flow

Total 158 participants were enrolled out of which 26 participants were randomized and treated.

Participant milestones

Participant milestones
Measure	BMS-919373 3/2 mg Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg\3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg\2) QD for 3 weeks.	BMS-919373 8/5 mg Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg\3 + 5 mg\1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg\*1) QD for 3 weeks.	BMS-919373 20/12 mg Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg\4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg\2 + 1 mg\*2) QD for 3 weeks.	Placebo Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Treatment Period STARTED	7	7	6	6
Treatment Period COMPLETED	7	5	4	4
Treatment Period NOT COMPLETED	0	2	2	2
Follow-up Period STARTED	7	5	4	4
Follow-up Period COMPLETED	6	5	4	4
Follow-up Period NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS-919373 3/2 mg Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg\3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg\2) QD for 3 weeks.	BMS-919373 8/5 mg Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg\3 + 5 mg\1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg\*1) QD for 3 weeks.	BMS-919373 20/12 mg Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg\4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg\2 + 1 mg\*2) QD for 3 weeks.	Placebo Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Treatment Period no longer meets study criteria	0	0	1	0
Treatment Period Poor/non-compliance	0	1	0	0
Treatment Period Lost to Follow-up	0	0	0	1
Treatment Period Withdrawal by Subject	0	0	1	0
Treatment Period Subject request to discontinue treatment	0	1	0	0
Treatment Period Adverse Event	0	0	0	1
Follow-up Period Withdrawal by Subject	1	0	0	0

Baseline Characteristics

A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS-919373 3/2 mg n=7 Participants Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg\3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg\2) QD for 3 weeks.	BMS-919373 8/5 mg n=7 Participants Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg\3 + 5 mg\1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg\*1) QD for 3 weeks.	BMS-919373 20/12 mg n=6 Participants Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg\4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg\2 + 1 mg\*2) QD for 3 weeks.	Placebo n=6 Participants Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.	Total n=26 Participants Total of all reporting groups
Age, Continuous	70.0 Years STANDARD_DEVIATION 5.83 • n=5 Participants	61.0 Years STANDARD_DEVIATION 8.23 • n=7 Participants	65.7 Years STANDARD_DEVIATION 10.05 • n=5 Participants	65.0 Years STANDARD_DEVIATION 10.77 • n=4 Participants	65.4 Years STANDARD_DEVIATION 8.90 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 8 to Day 29

Population: Data was not collected for any participants due to termination of the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 50

Population: All treated participants included all the participants who have received at least one dose of study treatment.

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	BMS-919373 3/2 mg n=7 Participants Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg\3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg\2) QD for 3 weeks.	BMS-919373 8/5 mg n=7 Participants Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg\3 + 5 mg\1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg\*1) QD for 3 weeks.	BMS-919373 20/12 mg n=6 Participants Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg\4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg\2 + 1 mg\*2) QD for 3 weeks.	Placebo n=6 Participants Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death AEs	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death Treatment-related AEs	0 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death Death	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose

Population: Data was not collected for any participants due to termination of the study

Cmax is defined as the maximum observed concentration of BMS-919373.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

Ctrough is defined as the minimum estimated plasma concentration at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Vc/F is a hypothetical volume into which a drug initially distributes upon administration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

Ka is the absorption rate constant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

Cavg is defines as the average concentration at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Population: Data was not collected for any participants due to termination of the study

AUC is defined as the area under the concentration-time curve at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 to Day 29

Population: Data was not collected for any participants due to termination of the study

The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both "System-triggered" and "Patient-triggered" results and report them separately. "System-triggered" results will include both symptomatic and asymptomatic findings, while "Patient-triggered" results will be the symptomatic ones triggered to report by patients. The analysis will be done both for "System-triggered" and for "Patient-triggered" results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 to Day 29

Population: Data was not collected for any participants due to termination of the study

The total number AF episodes were derived from AF episode histogram data over the monitoring period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8 to Day 29

Population: Data was not collected for any participants due to termination of the study

The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BMS-919373 3/2 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BMS-919373 8/5 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BMS-919373 20/12 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=6 participants at risk Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.	BMS-919373 3/2 mg n=7 participants at risk Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg\3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg\2) QD for 3 weeks.	BMS-919373 8/5 mg n=7 participants at risk Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg\3 + 5 mg\1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg\*1) QD for 3 weeks.	BMS-919373 20/12 mg n=6 participants at risk Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg\4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg\2 + 1 mg\*2) QD for 3 weeks.
Skin and subcutaneous tissue disorders Dermatitis Contact	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin Irritation	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Swelling Face	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Gastrointestinal disorders Abdominal Distension	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Gastrointestinal disorders Oral Pain	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
General disorders Energy Increased	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
General disorders Fatigue	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
General disorders Medical Device Site Dermatitis	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
General disorders Oedema Peripheral	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	28.6% 2/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Nervous system disorders Head Discomfort	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Nervous system disorders Tremor	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Infections and infestations Skin Infection	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Infections and infestations Staphylococcal Infection	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Choking Sensation	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoe	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Eye disorders Vision Blurred	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	14.3% 1/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.
Vascular disorders Thrombosis	0.00% 0/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	0.00% 0/7 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.	16.7% 1/6 • Approximately 50 days All treated participants included all the participants who have received at least one dose of study treatment.