Trial Outcomes & Findings for Study of Thymosin Beta 4 in Patients With Pressure Ulcers (NCT NCT00382174)

NCT ID: NCT00382174

Last Updated: 2010-02-01

Results Overview

All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: Up to 84 days
• Results posted on: 2010-02-01

Participant Flow

Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers.

Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin.

Participant milestones

Measure	Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Overall Study STARTED	18	54	72
Overall Study COMPLETED	14	37	51
Overall Study NOT COMPLETED	4	17	21

Reasons for withdrawal

Measure	Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Overall Study Lost to Follow-up	1	4	5
Overall Study Adverse Event	1	4	5
Overall Study Withdrawal by Subject	1	4	5
Overall Study Non compliance	1	0	1
Overall Study Physician Decision	0	2	2
Overall Study Failed to meet criteria	0	1	1
Overall Study Wounds merged	0	2	2

Baseline Characteristics

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Baseline characteristics by cohort

Measure	Placebo n=18 Participants 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses n=54 Participants 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	38 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	40 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	54 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 84 days

All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population

Outcome measures

Measure	Placebo n=18 Participants 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses n=54 Participants 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses n=72 Participants Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days	18 participants	53 participants	71 participants

SECONDARY outcome

Timeframe: Up to 84 days

Population: Analysis was per protocol,ITT, and using LOCF

Incidence of wound healing at the end of the study, Day 84

Outcome measures

Measure	Placebo n=18 Participants 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses n=54 Participants 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses n=72 Participants Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	3 Number of healed participants	8 Number of healed participants	11 Number of healed participants

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Tβ4 at 3 Doses

Serious events: 13 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo vs. Thymosin Beta 4 at 3 Doses

Serious events: 18 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Cardiac disorders Angina	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Chest pain	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Pyrexia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.7% 3/53 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Hepatobiliary disorders Cholecystitis	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Bacteraemia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Infected Skin Ulcer	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Lobar pneumonia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Osteomyelitis	11.1% 2/18 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Perianal Abscess	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Pneumonia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Sepsis	11.1% 2/18 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.6% 4/71 • Number of events 4 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Skin infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Urinary Tract Infection	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Urosepsis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Wound Infection staphylococcal	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Overdose	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Wound Complications	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Heart Rate Increased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Affective Disorder	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Confusional State	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.

Other adverse events

Measure	Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)	Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w	Placebo vs. Thymosin Beta 4 at 3 Doses Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
Blood and lymphatic system disorders Aneamia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Cardiac disorders Angina Pectoris	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Eye disorders Adreanal Insufficiency	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Endocrine disorders Hyperaldosteronism	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Eye disorders Conjunctivitis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Gastrointestinal disorders Dental Caries	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Gastrointestinal disorders Diarrhea	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Gastrointestinal disorders Nausea	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.7% 3/53 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Asthenia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Chest Pain	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Chills	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Inflammation	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Oedema Peripheral	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
General disorders Pyrexia	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	15.1% 8/53 • Number of events 8 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	12.7% 9/71 • Number of events 9 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Hepatobiliary disorders Cholecystitis	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Immune system disorders Hypersensitivity	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Abscess	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Bacteraemia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Bacterial Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Beta Haemolytic Streptococcal Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Candidiasis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Catheter Related Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Catheter Site Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Clostridium Difficile Colitis	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Fungal Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Infected Skin Ulcer	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Lobar Pneumonia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Nasopharyngitis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Oral Candidiasis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Osteomyelitis	11.1% 2/18 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.6% 4/71 • Number of events 4 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Otitis Media	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Perianal Abscess	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Pneumonia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.7% 3/53 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Sepsis	11.1% 2/18 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	9.4% 5/53 • Number of events 5 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	9.9% 7/71 • Number of events 7 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Skin Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Staphylococcal Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Upper Respiratory Tract Infection	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Urinary Tract Infection	22.2% 4/18 • Number of events 4 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	17.0% 9/53 • Number of events 9 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	18.3% 13/71 • Number of events 13 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Urosepsis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Vaginal Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Wound Infection	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.7% 3/53 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	4.2% 3/71 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Infections and infestations Wound Infection Staphylococcal	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Arteriovenous Fistula Site Complication	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Excoriation	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Overdose	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Thermal Burn	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Wound	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Wound Complication	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	7.5% 4/53 • Number of events 4 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	7.0% 5/71 • Number of events 5 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Injury, poisoning and procedural complications Wound Secretion	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Blood Albumin Decreased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Blood Cholesterol Decreased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Blood Potassium Decreased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Haematocrit Decreased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Haemoglobin Decreased	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Heart Rate Increased	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Investigations Oxygen Saturation Abnormal	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Nervous system disorders Headache	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Nervous system disorders Muscle Spasticity	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Affective Disorder	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Anxiety	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Confusional State	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Psychiatric disorders Depression	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Reproductive system and breast disorders Epididymitis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.7% 3/53 • Number of events 3 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	5.6% 4/71 • Number of events 4 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Decubitus Ulcer	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	3.8% 2/53 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	2.8% 2/71 • Number of events 2 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Skin Burning Sensation	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	0.00% 0/53 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Skin Maceration	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Skin Necrosis	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Surgical and medical procedures Tooth Extraction	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.
Vascular disorders Hypotension	0.00% 0/18 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.9% 1/53 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.	1.4% 1/71 • Number of events 1 • Adverse Events (AEs) were collected for 99 days AEs were collected at baseline, and weekly thereafter until Day 84 (End of Treatment) and at Day 99.

Additional Information

Nabila Turjman, PhD, Executive Director, Regulatory Affairs

RegeneRx Biopharmaceuticals, Inc.

Phone: 301-280-1992

Email: nturjman@regenerx.com

Results disclosure agreements

• Principal investigator is a sponsor employee RegeneRx (RGN) agreements may vary with individual PIs, but will not prohibit any PI from publishing. RGN supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER