Trial Outcomes & Findings for Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections (NCT NCT04042077)

NCT ID: NCT04042077

Last Updated: 2022-02-02

Results Overview

Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 268 participants
• Primary outcome timeframe: 7-14 days after last dose
• Results posted on: 2022-02-02

Participant Flow

Overall, the recruiment period lasted 13 months, since August 2019 to September 2020. The recruitment was mostly conducted at Abdominal and General surgery departments.

In total, 274 patients were screened while 266 patients were randomized and treated (ITT population).

Participant milestones

Measure	Best Available Therapy Cardiothoracic / related leg SSI * Vancomycin IV * Linezolid IV, with the option to switch to linezolid oral. In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice Abdominal SSI * Piperacillin/Tazobactam IV, OR * Tigecycline IV In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice. Vancomycin: Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days Linezolid: Solution for infusion or tablet, 600 mg BID, for 5 to 14 days Piperacillin/Tazobactam: Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days Tigecycline: Powder for solution for infusion 50 mg, TID, for 5 to 14 days	Delafloxacin Delafloxacin IV, with the option to switch to delafloxacin oral Delafloxacin: Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Overall Study STARTED	132	134
Overall Study Vancomycin IV	2	0
Overall Study Linezolid IV, With the Option to Switch to Linezolid Oral	8	0
Overall Study Piperacillin/Tazobactam IV	68	0
Overall Study Tigecycline IV	54	0
Overall Study COMPLETED	127	127
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Best Available Therapy Cardiothoracic / related leg SSI * Vancomycin IV * Linezolid IV, with the option to switch to linezolid oral. In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice Abdominal SSI * Piperacillin/Tazobactam IV, OR * Tigecycline IV In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice. Vancomycin: Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days Linezolid: Solution for infusion or tablet, 600 mg BID, for 5 to 14 days Piperacillin/Tazobactam: Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days Tigecycline: Powder for solution for infusion 50 mg, TID, for 5 to 14 days	Delafloxacin Delafloxacin IV, with the option to switch to delafloxacin oral Delafloxacin: Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Overall Study Adverse Event	1	0
Overall Study Death	1	2
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	2	3
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

Baseline characteristics by cohort

Measure	Delafloxacin n=134 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=132 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI	Total n=266 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 13.65 • n=5 Participants	63.7 years STANDARD_DEVIATION 13.71 • n=7 Participants	64.9 years STANDARD_DEVIATION 13.70 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	53 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	79 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	131 Participants n=5 Participants	131 Participants n=7 Participants	262 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants	132 Participants n=7 Participants	265 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Site of infection Abdominal SSI	124 Participants n=5 Participants	122 Participants n=7 Participants	246 Participants n=5 Participants
Site of infection Cardiothoracic SSI	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Depth of infection Superficial SSI	82 Participants n=5 Participants	79 Participants n=7 Participants	161 Participants n=5 Participants
Depth of infection Deep SSI	52 Participants n=5 Participants	53 Participants n=7 Participants	105 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7-14 days after last dose

Population: ITT population

Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions:

• Cure: The complete resolution of all baseline signs and symptoms of SSI
• Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.

Outcome measures

Measure	Delafloxacin n=134 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=132 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
Number of Participants With Clinical Success at Test Of Cure Visit	123 Participants	119 Participants

SECONDARY outcome

Timeframe: up to 14 days

Population: CE population

Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge

Outcome measures

Measure	Delafloxacin n=128 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=127 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
Hospital Infection Related Length of Stay (IRLOS)	130.9 hours Standard Deviation 71.87	140.3 hours Standard Deviation 68.98

SECONDARY outcome

Timeframe: up to 45 days (Late Follow Up visit)

Population: ITT population

Length of Stay since Screening till actual hospital discharge

Outcome measures

Measure	Delafloxacin n=134 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=132 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
Hospital Length of Stay (LOS)	178.8 hours Standard Deviation 95.44	193.5 hours Standard Deviation 119.72

SECONDARY outcome

Timeframe: up to 14 days

Population: ITT population

Blinded assessment based on patient stabilization and ability to tolerate OS diet. In particular, the following details had to be met:

Systolic blood pressure normal/not clinically significant abnormal No infection related tachycardia Afebrile status; body temperature <38°C for at least 24 hours* WBC count normalized/not clinically significant abnormal Patient able to tolerate PO diet/to take PO treatment and no GI absorption problem

The measure counts only the participants eligible to switch, without taking into account the actually switched. Indeed, only linezolid in the BAT has an equivalent oral formulation suitable for the switch.

Outcome measures

Measure	Delafloxacin n=134 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=132 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment	129 Participants	129 Participants

SECONDARY outcome

Timeframe: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)

Population: MITT population

Documented or presumed eradication or persistence

Outcome measures

Measure	Delafloxacin n=105 Participants Delafloxacin IV with the option to switch to OS	Best Available Therapy n=102 Participants Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI
Microbiological Response TOC Visit · Eradicated	94 Participants	81 Participants
Microbiological Response TOC Visit · Persisted	11 Participants	21 Participants
Microbiological Response EOT Visit · Eradicated	80 Participants	64 Participants
Microbiological Response EOT Visit · Persisted	25 Participants	38 Participants

Adverse Events

Delafloxacin

Serious events: 9 serious events

Other events: 22 other events

Deaths: 4 deaths

Best Available Therapy

Serious events: 14 serious events

Other events: 26 other events

Deaths: 1 deaths

Linezolid

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Piperacillin/Tazobactam

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Tigecycline

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Delafloxacin n=134 participants at risk Delafloxacin IV with the option to switch to delafloxacin OS	Best Available Therapy n=132 participants at risk Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI The results are not reported "per intervention" since the study was not powered to highlight difference between delafloxacin and each reference treatment. The safety analysis aimed to demonstrate that delafloxacin, among the fluoroquinolone class, is atypical showing a favourable safety profile very similar to NON-fluoroquinoles.	Linezolid n=8 participants at risk Linezolid IV with the option to switch to delafloxacin OS	Vancomycin n=2 participants at risk Vancomycin IV	Piperacillin/Tazobactam n=68 participants at risk Piperacillin/Tazobactam IV	Tigecycline n=54 participants at risk Tigecycline IV
Nervous system disorders cerebrovascular accident	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Respiratory, thoracic and mediastinal disorders pleural effusion	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	12.5% 1/8 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Respiratory, thoracic and mediastinal disorders pulmonary artery thrombosis	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Cardiac disorders angina pectoris	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Cardiac disorders cardiac arrest	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders enterocutaneous fistula	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders ileus	0.75% 1/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders intestinal perforation	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders small intestinal obstruction	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
General disorders death	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
General disorders malaise	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations abdominal wall abscess	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations clostridium difficile colitis	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations gas gangrene	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations infection	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations septic shock	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations wound infection	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Injury, poisoning and procedural complications abdominal wound dehiscence	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Injury, poisoning and procedural complications postoperative wound complications	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Injury, poisoning and procedural complications wound dehiscence	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 2/132 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Surgical and medical procedures surgery	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Vascular disorders deep vein thrombosis	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.

Other adverse events

Measure	Delafloxacin n=134 participants at risk Delafloxacin IV with the option to switch to delafloxacin OS	Best Available Therapy n=132 participants at risk Vancomycin and Linezolid for cardiothoracic SSI Piperacillin/Tazobactam and Tigecycline for abdominal SSI The results are not reported "per intervention" since the study was not powered to highlight difference between delafloxacin and each reference treatment. The safety analysis aimed to demonstrate that delafloxacin, among the fluoroquinolone class, is atypical showing a favourable safety profile very similar to NON-fluoroquinoles.	Linezolid n=8 participants at risk Linezolid IV with the option to switch to delafloxacin OS	Vancomycin n=2 participants at risk Vancomycin IV	Piperacillin/Tazobactam n=68 participants at risk Piperacillin/Tazobactam IV	Tigecycline n=54 participants at risk Tigecycline IV
Gastrointestinal disorders diarrhoea	2.2% 3/134 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	2.3% 3/132 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	3.7% 2/54 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders nausea	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
General disorders pyrexia	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 5 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 5 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations Hypokalaemia	2.2% 3/134 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 2/132 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	2.9% 2/68 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations hypophosphataemia	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Nervous system disorders headache	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	2.3% 3/132 • Number of events 3 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	3.7% 2/54 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Skin and subcutaneous tissue disorders pruritus	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Vascular disorders hypertension	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 2/132 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	2.9% 2/68 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Vascular disorders phlebitis	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Blood and lymphatic system disorders anaemia	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Blood and lymphatic system disorders anemia folate deficiency	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Blood and lymphatic system disorders anemia vitamin B12 deficiency	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Endocrine disorders thyroid mass	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Gastrointestinal disorders pancreatic calcification	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations device related infection	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations post-operative wound infection	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Infections and infestations urinary tract infection	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	12.5% 1/8 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations Blood alkaline phosphatase increased	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.9% 1/54 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations Blood potassium decreased	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	12.5% 1/8 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations White blood cell count increased	1.5% 2/134 • Number of events 2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/132 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/68 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Investigations hypomagnaesemia	0.75% 1/134 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Nervous system disorders paraesthesia	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.
Reproductive system and breast disorders vaginal haemorrhage	0.00% 0/134 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.76% 1/132 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/8 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/2 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	1.5% 1/68 • Number of events 1 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.	0.00% 0/54 • Adverse events were collected for each participant from the time of ICF signature (Screening) up to to LPLV, i.e. for maximum 45 days.

Additional Information

Corporate Director of Clinical Sciences

Menarini Ricerche S.p.A.

Phone: 0555680

Email: acapriati@menarini-ricerche.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60