Trial Outcomes & Findings for Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group (NCT NCT00634166)

NCT ID: NCT00634166

Last Updated: 2022-09-29

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

220 participants

Primary outcome timeframe

The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.

Results posted on

2022-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Historical Control Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Overall Study STARTED	82	138
Overall Study COMPLETED	22	78
Overall Study NOT COMPLETED	60	60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Total n=220 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 18.91 • n=5 Participants	44.7 years STANDARD_DEVIATION 17.87 • n=7 Participants	42.6 years STANDARD_DEVIATION 18.44 • n=5 Participants
Age, Customized <18 years	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants
Age, Customized >= 18 years	71 participants n=5 Participants	133 participants n=7 Participants	204 participants n=5 Participants
Sex/Gender, Customized Female	19 participants n=5 Participants	29 participants n=7 Participants	48 participants n=5 Participants
Sex/Gender, Customized Male	63 participants n=5 Participants	109 participants n=7 Participants	172 participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	138 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.	4.9 Percentage of Participants	4.3 Percentage of Participants

SECONDARY outcome

Timeframe: Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14

All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population	20.3 Percentage of participants	2.7 Percentage of participants

SECONDARY outcome

Timeframe: Days 18 to 21

All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population	4.5 Percentage of participants	6 Percentage of participants

SECONDARY outcome

Timeframe: Days 5-7

Treatment failure is defined as a change in topical antimicrobial therapy of initial meshed autograft due to suspected infection within the first 7 days or infectious graft loss.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population	13.4 Percentage of participants	1.4 Percentage of participants

SECONDARY outcome

Timeframe: Days 5-7

Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population	2.4 Percentage of participants	0.7 Percentage of participants

SECONDARY outcome

Timeframe: Days 12-14

Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population	3.4 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Days 18-21

Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.

Outcome measures

Outcome measures
Measure	Historical Control n=82 Participants Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 Participants Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population	0.0 Percentage of participants	1.3 Percentage of participants

Adverse Events

Historical Control

Serious events: 9 serious events

Other events: 74 other events

Deaths: 0 deaths

Prospective Patients/Active Drug

Serious events: 27 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Eric Davis, M.D.

Mylan Pharmaceuticals Inc.

Phone: 304.554.6503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator shall provide Sponsor with (i) a copy of the papers prepared for publication by him or her as soon as possible, but in any event not less than sixty (60) days prior to their submission to a scientific journal or other publication; or (ii) a reasonably detailed summary or abstract of any oral presentation not less than forty-five (45) days prior to their submission or presentation. Sponsor may comment and remove any confidential information as needed.
Publication restrictions are in place

Restriction type: OTHER

Measure	Historical Control n=82 participants at risk Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.	Prospective Patients/Active Drug n=138 participants at risk Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
Cardiac disorders Atrial Fibrillation	1.2% 1/82 • Number of events 1 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Cardiac disorders Bradycardia	1.2% 1/82 • Number of events 1 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Cardiac disorders Cardiac Arrest	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Cardiac disorders Tachycardia	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Gastrointestinal disorders Gastrointestinal Necrosis	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
General disorders Multi-organ Failure	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	2.9% 4/138 • Number of events 4 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Infections and infestations Pneumonia	1.2% 1/82 • Number of events 1 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	3.6% 5/138 • Number of events 5 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Infections and infestations Sepsis	2.4% 2/82 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	6.5% 9/138 • Number of events 12 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Renal and urinary disorders Renal Failure	1.2% 1/82 • Number of events 1 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	4.3% 6/138 • Number of events 6 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Renal and urinary disorders Renal Failure - acute	2.4% 2/82 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	2.9% 4/138 • Number of events 4 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	2.2% 3/138 • Number of events 3 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	1.4% 2/138 • Number of events 2 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	5.1% 7/138 • Number of events 8 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Vascular disorders Deep Vein Thrombosis	0.00% 0/82 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	6.5% 9/138 • Number of events 9 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Vascular disorders Hypotension	1.2% 1/82 • Number of events 1 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1	2.9% 4/138 • Number of events 4 There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1