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    Clinical Trial Results:
    A Randomized, Double-Blind, Double-Dummy Study Assessing the Safety and Tolerability of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis who are Inadequate Responders to or Intolerant of TNF Antagonists

    Summary
    EudraCT number
    2012-003536-23
    Trial protocol
    CZ   BE   HU   ES   IT   SE   EE   NO   FI   NL   GB   PL  
    Global end of trial date
    14 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFY13370
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01768572
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    14 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of sarilumab and tocilizumab in subjects with rheumatoid arthritis (RA) who are inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Mar 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
    Argentina: 30
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Mexico: 17
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Norway: 3
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    202
    EEA total number of subjects
    89
    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)
    173
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 78 centers in 19 countries. A total of 389 subjects were screened between 25 March 2013 and 02 April 2014, 187 of whom were screen failures. Screen failures were mainly due to failure to meet inclusion and exclusion criteria.

    Pre-assignment
    Screening details
    Randomization of subjects were stratified by region and screening value of absolute neutrophil count. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:1:2 (sarilumab 150 mg q2w: sarilumab 200 mg q2w: tocilizumab q4w). 202 subjects were randomized.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sarilumab 150 mg q2w
    Arm description
    Sarilumab 150 mg once every 2 weeks (q2w) and placebo (for Tocilizumab) once every 4 weeks (q4w) was added to one or a combination of the non-biologic disease modifying anti-rheumatic drug (DMARD) for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Sarilumab
    Investigational medicinal product code
    SAR153191, REGN88
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Sarilumab as a subcutaneous (SC) injection in the abdomen, thigh or upper arm.

    Investigational medicinal product name
    Placebo (for Tocilizumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo (for Tocilizumab) as a 60-minute single intravenous (IV) infusion.

    Arm title
    Sarilumab 200 mg q2w
    Arm description
    Sarilumab 200 mg q2w and placebo (for Tocilizumab) q4w was added to one or a combination of the non-biologic DMARD for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Sarilumab
    Investigational medicinal product code
    SAR153191, REGN88
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Sarilumab as a SC injection in the abdomen, thigh or upper arm.

    Investigational medicinal product name
    Placebo (for Tocilizumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo (for Tocilizumab) as a 60-minute single IV infusion.

    Arm title
    Tocilizumab q4w
    Arm description
    Tocilizumab 4 mg/kg or 8 mg/kg q4w and placebo (for Sarilumab) q2w was added to one or a combination of the non-biologic DMARD for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tocilizumab as a 60-minute single IV infusion. Dose for tocilizumab could be up-titrated to 8 mg/kg or dose down-titrated to 4 mg/kg based on clinical response as per Investigator's discretion.

    Investigational medicinal product name
    Placebo (for Sarilumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (for Sarilumab) as a SC injection in the abdomen, thigh or upper arm.

    Number of subjects in period 1
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
    Started
    49
    51
    102
    Completed
    40
    39
    96
    Not completed
    9
    12
    6
         Adverse event
    7
    8
    4
         Lack of efficacy
    1
    3
    1
         Other, not due to an adverse event
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg once every 2 weeks (q2w) and placebo (for Tocilizumab) once every 4 weeks (q4w) was added to one or a combination of the non-biologic disease modifying anti-rheumatic drug (DMARD) for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w and placebo (for Tocilizumab) q4w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Reporting group title
    Tocilizumab q4w
    Reporting group description
    Tocilizumab 4 mg/kg or 8 mg/kg q4w and placebo (for Sarilumab) q2w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Reporting group values
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w Total
    Number of subjects
    49 51 102 202
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.8 ± 12.1 51.7 ± 13.1 50.4 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    41 39 82 162
        Male
    8 12 20 40
    RA Functional Class
    RA Class I subjects: completely able to perform usual activities of daily living (self-care, vocational and avocational); Class II subjects: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III subjects: able to perform usual self-care activities, but limited in vocational and avocational activities; Class IV subjects: limited in ability to perform usual self-care, vocational and avocational activities.
    Units: Subjects
        Class I
    10 4 16 30
        Class II
    25 33 62 120
        Class III
    14 14 24 52
        Class IV
    0 0 0 0
    Duration of RA since diagnosis
    Units: years
        arithmetic mean (standard deviation)
    13.59 ± 8.24 10.45 ± 7.57 10.84 ± 8.91 -
    Health Assessment Questionnaire Disability Index (HAQ-DI)
    Subject-reported assessment of ability to perform tasks in 8 categories of daily living activities: HAQ-DI consists of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; activities rated on a 4-point scale where 0=best and 3=worst. Overall score was computed as the sum of domain scores and divided by the number of domains answered, ranging from 0 to 3, where 0 = no disability and 3 = very severe, high-dependency disability.
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.63 ± 0.66 1.71 ± 0.6 1.78 ± 0.63 -
    Disease Activity Score for 28 Joints- C-reactive protein (DAS28-CRP)
    The DAS28-CRP is a composite score that contains 4 variables: Tender Joints Count (based on 28 joints), Swollen Joints Count (based on 28 joints), general health assessment and high sensitivity C-reactive protein (hs-CRP) in mg/L or erythrocyte sedimentation rate (ESR) in mm/hr. It ranges from 0-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas a below 3.2 indicates low disease activity and below 2.6 as disease remission.
    Units: score on scale
        arithmetic mean (standard deviation)
    5.85 ± 0.92 5.88 ± 0.97 5.91 ± 1.01 -

    End points

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    End points reporting groups
    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg once every 2 weeks (q2w) and placebo (for Tocilizumab) once every 4 weeks (q4w) was added to one or a combination of the non-biologic disease modifying anti-rheumatic drug (DMARD) for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w and placebo (for Tocilizumab) q4w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Reporting group title
    Tocilizumab q4w
    Reporting group description
    Tocilizumab 4 mg/kg or 8 mg/kg q4w and placebo (for Sarilumab) q2w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    Adverse event (AE) was defined as any untoward medical occurrence in a subjects who received study drug and does not necessary had to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, were reported in AE section. Safety population consisted of all randomized subjects who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.
    End point type
    Primary
    End point timeframe
    Up to 211 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    Sarilumab 150 mg q2w Sarilumab 200 mg q2w Tocilizumab q4w
    Number of subjects analysed
    49
    51
    102
    Units: subjects
        Any TEAE
    33
    36
    68
        Any treatment-emergent SAE
    1
    3
    7
        Any TEAE leading to death
    0
    0
    1
        Any TEAE leading to discontinuation
    6
    8
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 211) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent that is AEs that developed/worsened that occurred during 'TEAE period' (first dose of study drug to last dose of study drug+60 days, last contact date, or the date of death, whichever came first). Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Tocilizumab q4w
    Reporting group description
    Tocilizumab 4 mg/kg or 8 mg/kg q4w and placebo (for Sarilumab) q2w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Reporting group title
    Sarilumab 200 mg q2w
    Reporting group description
    Sarilumab 200 mg q2w and placebo (for Tocilizumab) q4w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Reporting group title
    Sarilumab 150 mg q2w
    Reporting group description
    Sarilumab 150 mg q2w and placebo (for Tocilizumab) q4w was added to one or a combination of the non-biologic DMARD for 24 weeks.

    Serious adverse events
    Tocilizumab q4w Sarilumab 200 mg q2w Sarilumab 150 mg q2w
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 102 (6.86%)
    3 / 51 (5.88%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Transaminases Increased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure Acute
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Tocilizumab q4w Sarilumab 200 mg q2w Sarilumab 150 mg q2w
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 102 (64.71%)
    36 / 51 (70.59%)
    33 / 49 (67.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 51 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    4
    2
    0
    Vascular Fragility
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    4
    0
    0
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    1 / 102 (0.98%)
    4 / 51 (7.84%)
    4 / 49 (8.16%)
         occurrences all number
    1
    14
    4
    Fatigue
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Device Dislocation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Chills
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Malaise
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    0
    1
    Injection Site Rash
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Injection Site Pruritus
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    1
    8
    5
    Injection Site Macule
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    2
    Injection Site Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Nodule
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Papule
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Nodule
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Menstruation Irregular
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Ovarian Cyst
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Infusion Related Reaction
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    1
    2
    0
    Fall
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    2
    1
    1
    Contusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Accidental Overdose
         subjects affected / exposed
    9 / 102 (8.82%)
    3 / 51 (5.88%)
    1 / 49 (2.04%)
         occurrences all number
    11
    5
    1
    Ankle Fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Traumatic Haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Road Traffic Accident
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Post-Traumatic Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Overdose
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Muscle Strain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Joint Injury
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    5 / 102 (4.90%)
    2 / 51 (3.92%)
    1 / 49 (2.04%)
         occurrences all number
    5
    2
    1
    Glomerular Filtration Rate Increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases Increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Liver Function Test Abnormal
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil Count Increased
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Blood Cholesterol Increased
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    Blood Pressure Increased
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Neutrophil Count Decreased
         subjects affected / exposed
    3 / 102 (2.94%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    3
    1
    0
    Cardiac disorders
    Cardiac Failure Chronic
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Nasal Ulcer
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    3
    0
    0
    Cough
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Bronchiectasis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia Of Chronic Disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophilia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 102 (2.94%)
    8 / 51 (15.69%)
    6 / 49 (12.24%)
         occurrences all number
    3
    12
    15
    Lymphopenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Leukocytosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    Cerebral Ischaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    4 / 102 (3.92%)
    3 / 51 (5.88%)
    1 / 49 (2.04%)
         occurrences all number
    4
    3
    1
    Dysgeusia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    5 / 102 (4.90%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    9
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Ocular Hyperaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Dark Circles Under Eyes
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Ulcerative Keratitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Gastric Ulcer
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 51 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal Pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    1
    0
    2
    Mouth Ulceration
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 51 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    4
    3
    0
    Loose Tooth
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal Disorder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    Haematochezia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Irritable Bowel Syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    7 / 102 (6.86%)
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    7
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 51 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    Stomatitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Calculus Urinary
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Hydronephrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Dermatitis Allergic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus Generalised
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Rash Pruritic
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Ulcer
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle Haemorrhage
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Hand Deformity
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Back Pain
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 51 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    3
    2
    0
    Arthralgia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Spasms
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Rheumatoid Arthritis
         subjects affected / exposed
    6 / 102 (5.88%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    15
    0
    1
    Rheumatoid Nodule
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal Osteoarthritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal Pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Pain In Extremity
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    4
    0
    0
    Synovial Cyst
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    4 / 102 (3.92%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    4
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    6 / 102 (5.88%)
    1 / 51 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    6
    1
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Food Craving
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    Vitamin D Deficiency
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes Simplex
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    1
    0
    3
    Cystitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis Viral
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    0
    2
    Otitis Media
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    2
    0
    2
    Influenza
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 102 (3.92%)
    3 / 51 (5.88%)
    6 / 49 (12.24%)
         occurrences all number
    4
    4
    7
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    Onychomycosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Pyuria
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    1
    Periodontitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    0
    2
    Urinary Tract Infection
         subjects affected / exposed
    6 / 102 (5.88%)
    1 / 51 (1.96%)
    4 / 49 (8.16%)
         occurrences all number
    6
    1
    6
    Upper Respiratory Tract Infection
         subjects affected / exposed
    7 / 102 (6.86%)
    1 / 51 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    7
    1
    2
    Tracheitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea Versicolour
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea Pedis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth Infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginitis Trichomonal
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2013
    It included following changes: Guidance for female subjects of childbearing potential in this clinical trial was provided to comply with the Medicines and Healthcare products Regulatory Agency guidance's on contraceptive wording in Clinical Trials conducted in the United Kingdom.
    10 Sep 2013
    It included the following changes: - Added laboratory visits at Weeks 14, 18, and 22 for additional hematology assessments. - Inconsistencies were corrected within the protocol related to concomitant DMARD therapy. - Inconsistencies within the protocol were corrected related to blood sampling at Visit 2 (Day 1), Visit 9 (Day 113), and Visit 10 (Day 141); DNA blood sampling time for subjects; tocilizumab/placebo preparation; blood volumes to be drawn for DNA and protein biomarker samples; stratification at baseline during randomization period. - Updated the AEs of special interest with immediate notification section.

    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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