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    Clinical Trial Results:
    A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

    Summary
    EudraCT number
    		 2012-003971-20
    Trial protocol
    		 HU   CZ   ES   PL   LV   EE   BG   RO  
    Global end of trial date
    23 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CE01-300
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01756339
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 101317
    Sponsors
    Sponsor organisation name
    Cempra Pharmaceuticals, Inc.
    Sponsor organisation address
    6320 Quadrangle Drive, Suite 360, Chapel Hill, United States, NC 27517
    Public contact
    Clinical Trials Info, Cempra Pharmaceuticals, Inc, clinicaltrials@cempra.com
    Scientific contact
    Clinical Trials Info, Cempra Pharmaceuticals, Inc, clinicaltrials@cempra.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the noninferiority (NI) oral solithromycin compared with oral moxifloxacin with respect to the following EMA co-primary endpoints: clinical response assessed at Test of Cure (TOC), also called Short-term Follow-Up Visit (SFU), 5-10 days after the last dose of study drug, in the Intent to Treat (ITT) population and clinically evaluable (CE-SFU) population.
    Protection of trial subjects
    This study was conducted in compliance with the protocol and all regulatory requirements, in accordance with GCP, including International Conference on Harmonisation (ICH) guidelines, and in general conformity with the most recent version of the Declaration of Helsinki.
    Background therapy
    		 A single dose of a short-acting antibiotic (penicillins, cephalosporins [not ceftriaxone], tetracyclines, or trimethoprim-sulfamethoxazole) in the 7 days prior to enrolment was permitted (number of patient limited to 25% of the population).
    Evidence for comparator
    		 Moxifloxacin was chosen as the active comparator for multiple reasons. It has established efficacy in the treatment of CABP, with potent activity against key pathogens associated with CABP. Moxifloxacin is recommended empiric therapy for moderately severe CABP in the EU and USA. Additionally, moxifloxacin is available in IV and oral formulations, and thus is an appropriate comparator for both this study and Study CE01-301, the Phase 3 solithromycin IV-to-Oral CABP trial. It was also possible to define a common moxifloxacin regimen for all countries in which the study was conducted.
    Actual start date of recruitment
    03 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Romania: 106
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Bulgaria: 67
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 60
    Country: Number of subjects enrolled
    Latvia: 9
    Country: Number of subjects enrolled
    Argentina: 58
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Dominican Republic: 14
    Country: Number of subjects enrolled
    Ecuador: 34
    Country: Number of subjects enrolled
    Russian Federation: 146
    Country: Number of subjects enrolled
    South Africa: 102
    Country: Number of subjects enrolled
    United States: 190
    Worldwide total number of subjects
    860
    EEA total number of subjects
    302
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    568
    From 65 to 84 years
    281
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 860 patients were enrolled from 114 centers in Europe (448 patients), North America (224 patients), Latin America (106 patients), and South Africa (102 patients). The first patient was enrolled 03 January 2013, the last patient was enrolled 25 September 2014, and the final study visit was conducted 23 October 2014.

    Pre-assignment
    Screening details
    		 Eligible patients were males or females ≥18 years of age with an acute onset or worsening of at least 3 of the following signs and symptoms of CABP: cough, production of purulent sputum, shortness of breath (dyspnea), chest pain. And at least 1 of the following: fever, hypothermia, presence of pulmonary rales and/or pulmonary consolidation.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    A double-dummy design was utilized, with solithromycin placebo capsules identical in appearance to solithromycin capsules and moxifloxacin placebo over-encapsulated tablets identical in appearance to moxifloxacin over˗encapsulated tablets.All personnel involved with the evaluation of patient efficacy and safety were blind with the exception of an unblinded statistician who was responsible for generating tables for the Data Monitoring Committee (DMC) and the bioanalytical personnel.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solithromycin
    Arm description
    		 Solithromycin treatment group
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solithromycin
    Investigational medicinal product code
    CEM-101
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Oral solithromycin 800 mg (4×200 mg capsules) and 1 oral moxifloxacin placebo capsule. Days 2-5: Oral solithromycin 400 mg (2×200 mg capsules) and 1 oral moxifloxacin placebo capsule daily Days 6-7:2 Oral solithromycin placebo capsules and 1 oral moxifloxacin placebo capsule daily

    Arm title
    		 Moxifloxacin
    Arm description
    		 Moxifloxacin treatment group
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moxifloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Oral moxifloxacin 400 mg (1×400 mg over-encapsulated tablet) and 4 oral solithromycin placebo capsules Days 2-7: Oral moxifloxacin 400 mg (1×400 mg over-encapsulated tablet) and 2 oral solithromycin placebo capsules daily

    Number of subjects in period 1
    		Solithromycin Moxifloxacin
    Started
    426
    434
    Completed
    406
    413
    Not completed
    20
    21
         Adverse event, serious fatal
    6
    6
         Consent withdrawn by subject
    11
    6
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    2
         randomised in error
    -
    1
         Lost to follow-up
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Solithromycin
    Reporting group description
    		 Solithromycin treatment group

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin treatment group

    Reporting group values
    		 Solithromycin Moxifloxacin Total
    Number of subjects
    		 426 434 860
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 271 297 568
        From 65-84 years
    		 150 131 281
        85 years and over
    		 5 6 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.5 ( 14.7 ) 56.7 ( 15.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 199 205 404
        Male
    		 227 229 456
    PORT risk class
    PORT core reported in the eCRF
    Units: Subjects
        Port I
    		 1 0 1
        Port II
    		 209 223 432
        Port IIII
    		 168 173 341
        Port IV
    		 48 38 86

    End points

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    End points reporting groups
    Reporting group title
    Solithromycin
    Reporting group description
    		 Solithromycin treatment group

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin treatment group

    Subject analysis set title
    Solithromycin -ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The analysis set consists of all randomized patients regardless of whether or not the patient received study drug. A patient is considered randomized when the Investigator or Investigator’s designee receives the IWRS-generated randomization number.

    Subject analysis set title
    Moxifloxacin - ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set consists of all randomized patients regardless of whether or not the patient received study drug. A patient is considered randomized when the Investigator or Investigator’s designee receives the IWRS-generated randomization number.

    Subject analysis set title
    Solithromycin - Clinically Evaluable Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) populations will consist of all patients in the ITT population who also meet the criteria listed in the SAP, among them: met key inclusion criteria, did not met the exclusion criteria, completed the TOC Visit 5-10 days after the last dose of study drug, Received ≥2 doses of study drug during the first 48 hours if the patient is a clinical failure, received ≥3 doses of study drug during the first 72 hours if the patient is a clinical success, did not receive another systemic antibacterial from the first dose of study drug through EOT (end of treatment ) or through TOC with likely or documented activity against confirmed or potential CABP pathogens, received the correct study drug based on randomization assignment.

    Subject analysis set title
    Moxifloxacin- Clinically Evaluable Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) populations will consist of all patients in the ITT population who also meet the criteria listed in the SAP, among them: met key inclusion criteria, did not met the exclusion criteria, completed the TOC Visit 5-10 days after the last dose of study drug, Received ≥2 doses of study drug during the first 48 hours if the patient is a clinical failure, received ≥3 doses of study drug during the first 72 hours if the patient is a clinical success, did not receive another systemic antibacterial from the first dose of study drug through EOT (end of treatment ) or through TOC with likely or documented activity against confirmed or potential CABP pathogens, received the correct study drug based on randomization assignment.

    Primary: Clinical response-ITT at TOC: non-inferiority hypothesis

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    End point title
    		 Clinical response-ITT at TOC: non-inferiority hypothesis
    End point description
    Proportion of patients with clinical success of CABP symptoms. Clinical response rates at the TOC visit (or SFU visit) for the ITT Population is a co-primary endpoint of the study. Clinical response (Investigator assessment) is classified as success, failure, or indeterminate according to the definitions in the SAP.
    End point type
    Primary
    End point timeframe
    At Test of Cure (TOC) , i.e. 5-10 days after last dose of study drug.
    End point values
    		 Solithromycin Moxifloxacin
    Number of subjects analysed
    426 [1]
    434 [2]
    Units: number of patients (%)
        success
    360
    376
        failure
    49
    38
        indeterminate
    17
    20
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Non-inferiority hypothesis test (success)-ITT
    Statistical analysis description
    H0: Difference (Solithromycin treatment group minus Moxifloxacin treatment group) of clinical success rates ≤ -10%
    Comparison groups
    Solithromycin v Moxifloxacin
    Number of subjects included in analysis
    860
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference of clinical success rates
    Point estimate
    -2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 2.6
    Notes
    [3] - A non-inferiority margin of 10% was used.

    Primary: Clinical response- CE at TOC: non-inferiority hypothesis

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    End point title
    		 Clinical response- CE at TOC: non-inferiority hypothesis
    End point description
    Proportion of patients with clinical success of CABP symptoms at TOC for the Clinically Evaluable (CE) Population is a co-primary endpoint. Clinical response (Investigator assessment) is classified as success, failure or indeterminate according to the definition in the SAP.
    End point type
    Primary
    End point timeframe
    At TOC
    End point values
    		 Solithromycin Moxifloxacin
    Number of subjects analysed
    388 [4]
    390 [5]
    Units: number of patients (%)
        Success
    342
    356
        Failure
    46
    33
        Indeterminate
    0
    1
    Notes
    [4] - Clinically Evaluable Population
    [5] - Clinically Evaluable Population
    Statistical analysis title
    		 Non-inferiority hypotesis test (success) - CE
    Statistical analysis description
    H0: Difference (solithromycin minus Moxifloxacin treatment group) of clinical success rates ≤ -10%.
    Comparison groups
    Solithromycin v Moxifloxacin
    Number of subjects included in analysis
    778
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in clinical success rates
    Point estimate
    -3.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 1.1
    Notes
    [6] - A non-inferiority margin of 10% was used.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration to late follow-up visit (Day 28-35 after first dose of study drug).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Solithromycin
    Reporting group description
    		 -

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 -

    Serious adverse events
    		 Solithromycin Moxifloxacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 424 (6.60%)
    27 / 432 (6.25%)
         number of deaths (all causes)
    6
    6
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukaemia
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 424 (0.00%)
    2 / 432 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 424 (0.24%)
    2 / 432 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    2 / 424 (0.47%)
    2 / 432 (0.46%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 424 (0.00%)
    2 / 432 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular failure
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 424 (0.47%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatorenal syndrome
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroiditis subacute
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Empyema
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 424 (0.00%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 424 (1.42%)
    3 / 432 (0.69%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 424 (0.24%)
    1 / 432 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 424 (0.24%)
    0 / 432 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Solithromycin Moxifloxacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 424 (15.33%)
    62 / 432 (14.35%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 424 (2.12%)
    7 / 432 (1.62%)
         occurrences all number
    9
    7
    Headache
         subjects affected / exposed
    19 / 424 (4.48%)
    10 / 432 (2.31%)
         occurrences all number
    19
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 424 (3.54%)
    27 / 432 (6.25%)
         occurrences all number
    15
    28
    Nausea
         subjects affected / exposed
    13 / 424 (3.07%)
    16 / 432 (3.70%)
         occurrences all number
    13
    16
    Vomiting
         subjects affected / exposed
    9 / 424 (2.12%)
    9 / 432 (2.08%)
         occurrences all number
    9
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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