Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adu... | NCT03551210

Status Module

Name	Class
OCT Clinical Trials	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nemonoxacin	Experimental	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules).	Drug: Nemonoxacin Drug: Placebo (100 ml)
Tavanic®	Active Comparator	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet).	Drug: Tavanic Drug: Placebo (250 ml)

Name	Type	Description	Arm Group Labels	Other Names
Nemonoxacin	Drug	Solution for infusion, 500 mg (250 ml)	Nemonoxacin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With Clinical Success as Judged by the Investigator	Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved	Visit 4 (within 7-9 days after last dose)

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With Clinical Success as Judged by the Investigator	Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy	Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)

Other Outcomes

Measure	Description	Time Frame
Nemnoxacin Concentration Changes	Cmax - The peak Nemonoxacin concentration at Day 1-2 of treatment C-22.5hours - 22.5-h drug concentration of Nemonoxacin	Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment
Area Under the Concentration-time Curve (AUC) of Nemonoxacin

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained from the patient.
Patients with moderate to severe community-acquired pneumonia who need inpatient treatment but do not need intensive care unit treatment.
The presence of at least 3 of the following symptoms / signs:
1. cough;
2. purulent sputum production;
3. tachypnea (respiratory rate > 24 breathes/minute);
4. chills;
5. fever (rectal / tympanic temperature ≥ 38.5°C or axillary / oral / skin temperature ≥ 38.5°C);
6. white blood cells (WBC) count of ≥ 10.0 x 10^9/L or ≥ 15% immature neutrophils (bands; regardless of peripheral WBC count).
Radiological evidence of (a) new infiltrate(s) consistent with bacterial pneumonia at baseline.
Treatment-naive patients or patients who have received single dose of a short-acting antibacterial drug within 24 hours of enrollment or patients with treatment failure who have received antibiotics (with the exception of quinolones or fluoroquinolones) for less than 72 hours.
Consent to use contraception during participation in the study (for women of childbearing potential and men).

Exclusion Criteria:

Known hypersensitivity to quinolones, fluoroquinolones or any of the excipients.
Female patients who are pregnant or nursing.
History of tendon disease / disorder related to quinolone treatment.
Known congenital or documented-acquired QT / QTc(F) prolongation on ECG (QTc(F) interval more than 450 ms); concomitant use of drugs, reported to increase the QT interval; uncorrected hypokalaemia and uncorrected hypomagnesemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias.
History of bronchiectasis, cystic fibrosis, bronchial obstructions excluding chronic obstructive pulmonary disease.
History of epilepsy and/or history of psychotic disorder.
Patients with history of myasthenia gravis.
Patients with diabetes mellitus.
Known glucose-6-phosphate dehydrogenase deficiency.
Active hepatitis or decompensated cirrhosis.
Alanine transaminase or aspartate transaminase increase > 3 fold upper limit of normal (ULN).
Patients with creatinine ≥ 1.1 fold ULN.
Patients requiring concomitant systemic or inhaled antibiotics (e.g., tobramycin).
Known or suspected active tuberculosis or endemic fungal infection.
Concomitant immunosuppressive therapy including a long-term (more than 2 weeks) treatment with oral or intravenous glucocorticoids at doses of 20 mg and higher of prednisone daily or an equivalent dose of other glucocorticoids.
Patients known to have HIV-positive status or AIDS or known to have other disease that seriously affects the immune system such as active haematological or solid organ malignancy, or splenectomy.
History of drug or alcohol abuse.
Patients have received quinolones or fluoroquinolones within 14 days before enrollment.
Previous enrolment in this study or participation in another study within the previous 4 weeks.
Patients with any severe medical condition as determined by medical history that, in the opinion of the investigator, does not allow the patient to carry out all planned procedure of the protocol.

Name	Affiliation	Role
Mikhail Samsonov	R-Pharm	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Regional budget healthcare institution "Ivanovo regional clinical hospital"		Ivanovo			Russia
City clinical hospital #1 n.a. N.I. Pirogov of Moscow Healthcare Department

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 26, 2017

Arm/Group Information

ID	Title	Description
BG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
BG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With Clinical Success as Judged by the Investigator

Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved

Modified Intent-To-Treat population (mITT) - all randomized patients received at least one dose of investigational drugs, in compliance with at lest minimal disease criteria (inclusion criteria 3 and 4) and had at least one assessment of clinical efficacy in this study

Posted

Count of Participants

Participants

Visit 4 (within 7-9 days after last dose)

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Units	Counts
Participants	OG000169 OG001166

Title

Denominators

Categories

Title	Measurements
Clinical success	OG000158 OG001145
Clinical non-efficacy	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	6.1			2-Sided	95	-0.7	13.0					Non-Inferiority	The non-inferiority bound was designated at the level of -15%
OG000 OG001		Regression, Logistic

Secondary

Number of Patients With Clinical Success as Judged by the Investigator

Posted

Count of Participants

Participants

Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Secondary

Number of Patients With Infection Relapse

All patients of mITT population achieved clinical success on Visit 4

Posted

Count of Participants

Participants

Visit 5 (within 21-23 days after last dose)

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Secondary

Time to Switch Therapy From Intravenous to Oral Therapy

Posted

Median

Inter-Quartile Range

days

Up to Visit 2 (day 4/8 ot treatment)

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Secondary

Number of Patients Required for Other Antibiotic Treatment

Posted

Count of Participants

Participants

Up to 21-23 days after last dose

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Secondary

Number of Patients With Microbiological Success

Microbiological response is evaluated as microbiological success if culture study demonstrates eradication of pathogen or no material available for culture because of clinical success

b-mITT - Patients in the mITT population whose bacterial culture had at least one baseline bacterial isolate

Posted

Count of Participants

Participants

Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion
OG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion

Other Pre-specified

Nemnoxacin Concentration Changes

Cmax - The peak Nemonoxacin concentration at Day 1-2 of treatment

C-22.5hours - 22.5-h drug concentration of Nemonoxacin

All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Posted

Mean

Standard Deviation

ng/ml

Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion

Units	Counts
Participants	OG000

Other Pre-specified

Area Under the Concentration-time Curve (AUC) of Nemonoxacin

AUC (0-22.5) - Area under the concentration-time curve from 0 to 22.5 hours of Nemonoxacin

AUC(0-∞) - Areas under the concentration-time curve from 0 h to infinity of Nemonoxacin

All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Posted

Mean

Standard Deviation

hours*ng/ml

Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

ID	Title	Description
OG000	Nemonoxacin	Blood sample collection for pharmacokinetic (PK) parameters was withdrawn on Day 1 and 2 of Visit 1 before and after the first infusion only in 40 first patients enrolled in the investigational sites defined by the Sponsor.

Units	Counts
Participants	OG000

Other Pre-specified

Сlearance (CL) of Nemonoxacin

Total systemic clearance of Nemonoxacin

All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Posted

Mean

Standard Deviation

ml/min

Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion

Units	Counts
Participants	OG000

Other Pre-specified

Volume of Distribution at Steady State (Vss) of Nemonoxacin

Volume of distribution at steady state of Nemonoxacin

All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Posted

Mean

Standard Deviation

liters

Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion

Units	Counts
Participants	OG000

Other Pre-specified

Terminal Elimination Half-life (T1/2) of Nemonoxacin

Terminal elimination half-life of Nemonoxacin

All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Posted

Mean

Standard Deviation

hours

Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

ID	Title	Description
OG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nemonoxacin	Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	0	171	0	171	86	171
EG001	Tavanic®	Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion	0	169	2	169	67	169

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG00015 events14 affected171 at risk EG0019 events9 affected169 at risk
Platelet count increased	Investigations	MedDRA 20.1	Systematic Assessment	EG00010 events10 affected171 at risk EG0017 events7 affected169 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG00010 events10 affected171 at risk EG0015 events5 affected169 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0006 events6 affected171 at risk EG0016 events6 affected169 at risk
Blood creatinine increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0014 events4 affected169 at risk
Red blood cell sedimentation rate increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0014 events4 affected169 at risk
Blood glucose increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected171 at risk EG0011 events1 affected169 at risk
Eosinophil count increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0013 events3 affected169 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0012 events2 affected169 at risk
Blood potassium increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0012 events2 affected169 at risk
Transaminases increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected171 at risk EG0010 events0 affected169 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0010 events0 affected169 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0010 events0 affected169 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00010 events10 affected171 at risk EG0016 events6 affected169 at risk
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0009 events4 affected171 at risk EG0010 events0 affected169 at risk
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected171 at risk EG0010 events0 affected169 at risk
Injection site reaction	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected171 at risk EG0010 events0 affected169 at risk
Injection site hypoaesthesia	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 events2 affected171 at risk EG0010 events0 affected169 at risk
HIV infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0013 events3 affected169 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected171 at risk EG0012 events2 affected169 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0010 events0 affected169 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0010 events0 affected169 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 events2 affected171 at risk EG0010 events0 affected169 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0011 events1 affected169 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected171 at risk EG0012 events2 affected169 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0006 events6 affected171 at risk EG0010 events0 affected169 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0012 events2 affected169 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected171 at risk EG0012 events2 affected169 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected171 at risk EG0013 events3 affected169 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected171 at risk EG0011 events1 affected169 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected171 at risk EG0012 events2 affected169 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0003 events2 affected171 at risk EG0010 events0 affected169 at risk

ID	Term
D018410	Pneumonia, Bacterial
D000098968	Community-Acquired Pneumonia

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D017714	Community-Acquired Infections

ID	Term
C543520	nemonoxacin
D015242	Ofloxacin
D064704	Levofloxacin

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds