Trial Outcomes & Findings for Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection (NCT NCT03915470)

Last Updated: 2023-10-16

Results Overview

To demonstrate the efficacy of a 0.2% XF-73 nasal gel in reducing the microbiological burden of nasal S. aureus measured as change in colony forming units (CFU) per millilitre (mL) from baseline to immediately prior to surgery in a patient population at risk of post-operative staphylococcal infection

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

Baseline (Day-10 to Day-1) to immediately prior to surgery (Day 0)

Results posted on

2023-10-16

Participant Flow

Participants at risk of post surgery staphylococcal infections were recruited based on physician assessment across 20 sites (14 enrolling) between June 2019 and March 2021. The first participant was enrolled on 29 August 2019 and the last participant was enrolled on 29 December 2020.

124 enrolled participants

Participant milestones

Participant milestones
Measure	XF-73 Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Overall Study STARTED	63	61
Overall Study COMPLETED	57	59
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	XF-73 Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Overall Study Death	3	1
Overall Study Adverse Event	1	0
Overall Study Physician Decision	1	0
Overall Study XF-73: Failure to meet RND criteria, Placebo: Surgery was cancelled	1	1

Baseline Characteristics

Intent-To-Treat Population Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XF-73 n=63 Participants 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel for a cumulative dose of 6.0 mg of XF-73. XF-73: XF-73 is a dicationic porphyrin derivative having potent bactericidal properties with a novel mode of action.	Placebo n=61 Participants 0.3 mL applications in each naris of placebo to match XF-73 nasal gel. Placebo: Placebo to match XF-73 nasal gel for colour and viscosity.	Total n=124 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 9.93 • n=63 Participants	61.2 years STANDARD_DEVIATION 8.79 • n=61 Participants	60.9 years STANDARD_DEVIATION 9.36 • n=124 Participants
Sex: Female, Male Female	17 Participants n=63 Participants	13 Participants n=61 Participants	30 Participants n=124 Participants
Sex: Female, Male Male	46 Participants n=63 Participants	48 Participants n=61 Participants	94 Participants n=124 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=63 Participants	3 Participants n=61 Participants	4 Participants n=124 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=63 Participants	56 Participants n=61 Participants	115 Participants n=124 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=63 Participants	2 Participants n=61 Participants	5 Participants n=124 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Race (NIH/OMB) Asian	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Race (NIH/OMB) Black or African American	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Race (NIH/OMB) White	63 Participants n=63 Participants	61 Participants n=61 Participants	124 Participants n=124 Participants
Race (NIH/OMB) More than one race	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=63 Participants	0 Participants n=61 Participants	0 Participants n=124 Participants
Region of Enrollment United States	4 participants n=63 Participants	2 participants n=61 Participants	6 participants n=124 Participants
Region of Enrollment Georgia	55 participants n=63 Participants	56 participants n=61 Participants	111 participants n=124 Participants
Region of Enrollment Serbia	4 participants n=63 Participants	3 participants n=61 Participants	7 participants n=124 Participants
Body Mass Index (BMI)	30.410 kg/m^2 STANDARD_DEVIATION 4.4140 • n=62 Participants • Intent-To-Treat Population Set	30.055 kg/m^2 STANDARD_DEVIATION 4.7368 • n=59 Participants • Intent-To-Treat Population Set	30.237 kg/m^2 STANDARD_DEVIATION 4.5586 • n=121 Participants • Intent-To-Treat Population Set

PRIMARY outcome

Timeframe: Baseline (Day-10 to Day-1) to immediately prior to surgery (Day 0)

Population: microbiological Intent-To-Treat (micro ITT) set: all patients who were randomized, received at least 1 dose of study drug, have at least 1 post-baseline assessment of S. aureus log10 CFU/mL and who have a log10 CFU/mL result at baseline greater than 0, i.e. all patients in the mITT set with a quantifiable baseline microbiological result.

Outcome measures

Outcome measures
Measure	XF-73 n=43 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=40 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Change in S. Aureus Log CFU/mL From Baseline to Pre-surgery	-2.842 log10 (CFU/mL) Standard Deviation 1.8552	-0.469 log10 (CFU/mL) Standard Deviation 1.3697

SECONDARY outcome

Timeframe: From baseline (day -10 to Day -1) to immediately post surgery (Day 0)

To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up after last administration.

Outcome measures

Outcome measures
Measure	XF-73 n=43 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=40 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Change in S. Aureus Log CFU/mL From Baseline to Immediately Post-surgery	-2.773 log10 (CFU/mL) Standard Deviation 1.8531	-0.314 log10 (CFU/mL) Standard Deviation 1.7674

SECONDARY outcome

Timeframe: From baseline to follow-up at 48 hours after surgery

To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up 48 hours after last administration.

Outcome measures

Outcome measures
Measure	XF-73 n=43 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=40 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Change in S. Aureus Log CFU/mL From Baseline to 48 Hours After Surgery	-2.700 log10 (CFU/mL) Standard Deviation 1.7362	-1.477 log10 (CFU/mL) Standard Deviation 1.6222

SECONDARY outcome

Timeframe: From baseline to follow-up Day 6 ± 24hours after surgery

To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up 7 days after last administration.

Outcome measures

Outcome measures
Measure	XF-73 n=43 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=40 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Change in S. Aureus Log CFU/mL From Baseline to Immediately After Surgery to 6 Days (± 24hours) After Surgery	-3.106 log10 (CFU/mL) Standard Deviation 1.7995	-2.399 log10 (CFU/mL) Standard Deviation 1.6933

SECONDARY outcome

Timeframe: From immediately post-surgery to 30 days post surgery (90 days in the case of foreign implant)

Population: Number of microITT patients with post-operative S.aureus infections microbiological Intent-To-Treat (micro ITT) set: all patients who were randomized, received at least 1 dose of study drug, have at least 1 post-baseline assessment of S. aureus log10 CFU/mL and who have a log10 CFU/mL result at baseline greater than 0, i.e. all patients in the mITT set with a quantifiable baseline microbiological result.

To assess the effect of XF-73 on S. aureus nasal carriage in the prevention of post-operative staphylococcal infections (surgical site infection, blood stream infections, and others) during the 30 days post-surgery (90 days in the case of a foreign implant).

Outcome measures

Outcome measures
Measure	XF-73 n=43 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=40 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Number of Participants With Staphylococcal Post-operative Infections During the 30-day Period After Surgery (90 Days in the Case of Foreign Implant)	0 participants	0 participants

SECONDARY outcome

Timeframe: Immediately prior to surgery until Day 6 ± 24hours.

Population: Total number of TEAEs in the safety set Safety set: all patients who received at least 1 dose of study treatment

To describe the safety and tolerability of multiple administrations of a 0.2% XF-73 nasal gel in a population of surgical patients at risk of post-operative staphylococcal infections.

Outcome measures

Outcome measures
Measure	XF-73 n=63 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=61 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Incidence of Treatment-emergent Adverse Events From the First Dose of Study Medication to 6 Days (± 24hours) After Last Dose of Study Medication.	67 events	68 events

SECONDARY outcome

Timeframe: From Randomisation (Day -10 to Day -1) until 48hours ± 24hours post surgery.

Population: Number of patients in the safety set with clinically significant changes in nasal examination at 48h ± 24h Safety set: all patients who received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	XF-73 n=63 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=61 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Changes in Nasal Examination.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Randomisation (Day -10 to Day -1) until Day 6 ± 24hours post surgery

Population: Safety set: all patients who received at least 1 dose of study drug

To describe the safety and tolerability of multiple administrations of a 0.2% XF-73 nasal gel in a population of surgical patients at risk of post-operative staphylococcal infections by comparison of Brief Smell Identification Test (B-SIT) score, assessment and percentile ranking changes from prior to first dose until Day 6 ±24h post surgery. Patients are asked to identify 12 unique smells; the more smells they identify correctly the higher the score (0-12). Comparison of the individual patient score is then made against their expected percentile ranking dependent on age and sex of the general population to determine if their percentile ranking is normal, abnormal relative to age or deficit relative to younger persons.

Outcome measures

Outcome measures
Measure	XF-73 n=63 Participants Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=61 Participants Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Changes in Brief Smell Identification Test (B-SIT). Assessed as 'Deficit relative to younger persons' at Day 6 ±24h post surgery	4 Participants	5 Participants
Changes in Brief Smell Identification Test (B-SIT). Assessed as 'Below percentile rank' at Day 6 ±24h post surgery	0 Participants	0 Participants
Changes in Brief Smell Identification Test (B-SIT). Participants did not complete	5 Participants	2 Participants
Changes in Brief Smell Identification Test (B-SIT). Assessed as 'Normal' at Day 6 ±24h post surgery	52 Participants	50 Participants
Changes in Brief Smell Identification Test (B-SIT). Assessed as 'Abnormal relative to age' at Day 6 ±24h post surgery	2 Participants	1 Participants
Changes in Brief Smell Identification Test (B-SIT). Assessed as 'Not Done' at Day 6 ±24h post surgery	0 Participants	3 Participants

Adverse Events

XF-73

Serious events: 4 serious events

Other events: 31 other events

Deaths: 2 deaths

Placebo

Serious events: 5 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	XF-73 n=63 participants at risk Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=61 participants at risk Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Vascular disorders Hypotension	1.6% 1/63 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	0.00% 0/61 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Cardiac Arrest	0.00% 0/63 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	1.6% 1/61 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Coronary artery occlusion	0.00% 0/63 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	1.6% 1/61 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Angina unstable	1.6% 1/63 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	1.6% 1/61 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Cardiogenic shock	1.6% 1/63 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	0.00% 0/61 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Infections and infestations Asymptomatic COVID-19	1.6% 1/63 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	0.00% 0/61 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Renal and urinary disorders Acute kidney injury	0.00% 0/63 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	1.6% 1/61 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Acute left ventricular failure	1.6% 1/63 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	0.00% 0/61 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Cardiac tamponade	0.00% 0/63 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	1.6% 1/61 • Number of events 1 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit

Other adverse events

Other adverse events
Measure	XF-73 n=63 participants at risk Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.	Placebo n=61 participants at risk Participants received 0.3 mL applications in each naris of placebo to match XF-73 nasal gel, 4 times in one day prior to surgery and once more after surgery. Note: Placebo to match XF-73 nasal gel for colour and viscosity.
Blood and lymphatic system disorders Anaemia	7.9% 5/63 • Number of events 5 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	9.8% 6/61 • Number of events 6 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.4% 16/63 • Number of events 16 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	23.0% 14/61 • Number of events 14 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Pericardial effusion	7.9% 5/63 • Number of events 5 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	8.2% 5/61 • Number of events 5 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit
Cardiac disorders Atrial Fibrillation	7.9% 5/63 • Number of events 5 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit	6.6% 4/61 • Number of events 6 • From screening until 7 days after a subject received first dose Non-treatment emergent AEs: recorded from the time when the patient is enrolled into the study until first administration of study drug, TEAEs: First Administration of Study Drug to Patient's Day 6 visit, Only AEs that meet SAE criteria and are considered related with the study medication by the investigator will be recorded after Day 6 through the final follow up visit

Additional Information

Clinical Project Manager

Destiny Pharma

Phone: +44 (0)1273-704440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Protocol limits Investigators to not publish any data (poster, abstract, paper, etc.) without having consulted with the Sponsor in advance.
Publication restrictions are in place

Restriction type: OTHER