Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effect of Teriparatide on Femoral Neck Fracture Healing

    Summary
    EudraCT number
    2010-021395-28
    Trial protocol
    SE   ES   LV   FI   NO   LT   EE   DK  
    Global end of trial date
    04 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    B3D-MC-GHDN
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01473589
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Alias: B3D-MC-GHDN, Trial Number: 13467
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    04 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the effect of 6 months of treatment with teriparatide 20 microgram(µg)/day versus placebo on the proportion of men and postmenopausal women 50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 2012
    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
    Denmark: 2
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Taiwan: 19
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    India: 3
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Japan: 29
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Latvia: 5
    Country: Number of subjects enrolled
    Sweden: 1
    Worldwide total number of subjects
    122
    EEA total number of subjects
    27
    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)
    44
    From 65 to 84 years
    58
    85 years and over
    20

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    No text entered.

    Pre-assignment
    Screening details
    No text entered.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Teriparatide
    Arm description
    Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Teriparatide
    Investigational medicinal product code
    Other name
    Forteo, Forsteo, LY333334
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.

    Investigational medicinal product name
    Calcium supplementation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The supplement dose for calcium should be up to approximately 1000 milligram (mg)/day elemental calcium starting as soon as possible after screening and continuing through 12 months.

    Investigational medicinal product name
    Vitamin D supplementation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During screening, approximately 1000 International Unit (IU)/day vitamin D. The dose of vitamin D may then be increased at the discretion of the investigator.

    Arm title
    Placebo
    Arm description
    Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.

    Investigational medicinal product name
    Vitamin D supplementation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During screening, approximately 1000 IU/day vitamin D. The dose of vitamin D may then be increased at the discretion of the investigator.

    Investigational medicinal product name
    Calcium supplementation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The supplement dose for calcium should be up to approximately 1000 mg/day elemental calcium starting as soon as possible after screening and continuing through 12 months.

    Number of subjects in period 1
    Teriparatide Placebo
    Started
    60
    62
    Received at Least 1 Dose of Study Drug
    60
    61
    Completed 6 Months
    51
    54
    Completed 12 Months
    49
    48
    Completed
    49
    46
    Not completed
    11
    16
         Protocol deviation
    1
    -
         Physician decision
    -
    1
         Adverse event, serious fatal
    2
    -
         Adverse event, non-fatal
    1
    1
         'Entry criteria not met '
    -
    1
         Consent withdrawn by subject
    5
    11
         Lost to follow-up
    2
    2

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group values
    Teriparatide Placebo Total
    Number of subjects
    60 62 122
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    68.49 ± 11.321 70.96 ± 12.023 -
    Gender categorical
    Units: Subjects
        Female
    43 44 87
        Male
    17 17 34
        Not recorded
    0 1 1
    Surgical screw type
    Surgical screws used in initial surgery to repair femur neck hip fracture.
    Units: Subjects
        Cancellous Screws
    54 53 107
        Sliding Hip Screws
    6 8 14
        Not recorded
    0 1 1
    Ethnicity (NIH/OMB)
    Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.
    Units: Subjects
        Hispanic or Latino
    0 1 1
        Not Hispanic or Latino
    26 27 53
        Unknown or Not Reported
    34 33 67
        Not recorded
    0 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    35 34 69
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    0 0 0
        White
    25 27 52
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0
        Not recorded
    0 1 1
    Region of Enrollment
    Units: Subjects
        United States
    1 1 2
        Spain
    7 8 15
        Taiwan
    10 9 19
        Lithuania
    2 2 4
        Israel
    3 4 7
        India
    2 1 3
        Canada
    3 1 4
        Denmark
    1 1 2
        Australia
    1 0 1
        Latvia
    2 3 5
        Japan
    14 15 29
        New Zealand
    5 7 12
        Korea, Republic of
    9 9 18
        Sweden
    0 1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Baseline characteristics values based on number of subjects that received at least 1 dose of study drug.

    Primary: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture

    Close Top of page
    End point title
    Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
    End point description
    Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    60
    61
    Units: percentage of participants
        number (confidence interval 90%)
    87 (77 to 93)
    86 (76 to 92)
    Statistical analysis title
    Statistical Analysis 1 for End Point 1
    Comparison groups
    Teriparatide v Placebo
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.743 [1]
    Method
    K-M with Greenwood SE
    Parameter type
    Difference in proportion
    Point estimate
    -0.04
    Confidence interval
         level
    90%
         sides
    1-sided
         lower limit
    -0.14
         upper limit
    -
    Notes
    [1] - P-value is based on Z test statistic with Greenwood estimator for standard errors (SE) to compare two Kaplan-Meier (K-M) estimates at 12 month.

    Secondary: Percentage of Participants With Radiographic Evidence of Healing

    Close Top of page
    End point title
    Percentage of Participants With Radiographic Evidence of Healing
    End point description
    The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    Randomization, 12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    60
    61
    Units: percentage of participants
    78
    79
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Pain Control During Ambulation

    Close Top of page
    End point title
    Percentage of Participants With Pain Control During Ambulation
    End point description
    The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    47
    49
    Units: percentage of participants
    91
    90
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit

    Close Top of page
    End point title
    Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
    End point description
    The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    50
    51
    Units: percentage of participants
    88
    82
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing

    Close Top of page
    End point title
    Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
    End point description
    The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    47
    50
    Units: percentage of participants
    89
    88
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Functional Evidence of Healing

    Close Top of page
    End point title
    Percentage of Participants With Functional Evidence of Healing
    End point description
    Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    48
    50
    Units: percentage of participants
    85
    74
    No statistical analyses for this end point

    Secondary: Percentage of Participants Able to Ambulate

    Close Top of page
    End point title
    Percentage of Participants Able to Ambulate
    End point description
    Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    48
    50
    Units: percentage of participants
    98
    98
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Regain Their Prefracture Ambulatory Status

    Close Top of page
    End point title
    Percentage of Participants Who Regain Their Prefracture Ambulatory Status
    End point description
    Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    56
    58
    Units: percentage of participants
    73
    57
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain

    Close Top of page
    End point title
    Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
    End point description
    The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    47
    50
    Units: units on a scale
    least squares mean (standard error)
        During ambulation
    0.2 ± 0.37
    0.2 ± 0.36
        During 24 hours preceding visit
    -0.3 ± 0.45
    -0.8 ± 0.42
        On weight bearing
    0.7 ± 0.39
    0.8 ± 0.36
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months in Gait Speed

    Close Top of page
    End point title
    Mean Change From Baseline to 6 Months in Gait Speed
    End point description
    The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    45
    47
    Units: m/s
        least squares mean (standard error)
    -0.672 ± 2.128
    1.524 ± 2.018
    No statistical analyses for this end point

    Secondary: Time to Revision Surgery

    Close Top of page
    End point title
    Time to Revision Surgery
    End point description
    Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
    End point type
    Secondary
    End point timeframe
    Baseline, Revision surgery
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    60
    59
    Units: days
        median (full range (min-max))
    358.5 (15 to 430)
    350 (12 to 412)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores

    Close Top of page
    End point title
    Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
    End point description
    SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    58
    59
    Units: units on a scale
    least squares mean (standard error)
        PCS Month 6 (n = 49, 49)
    -3.73 ± 1.2
    -4.75 ± 1.2
        MCS Month 6 (n = 49, 49)
    -0.58 ± 2.1
    -0.49 ± 2.1
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)

    Close Top of page
    End point title
    Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
    End point description
    WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    58
    59
    Units: units on a scale
    least squares mean (standard error)
        Physical Function Score - Month 6 (n=48, 51)
    12.9 ± 4.36
    12.8 ± 4.25
        Pain Score - Month 6 ( n = 51, 51)
    8.2 ± 3.76
    10.3 ± 3.68
        Stiffness Score - Month 6 (n = 51, 51)
    13.1 ± 3.78
    11.8 ± 3.75
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score

    Close Top of page
    End point title
    Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
    End point description
    The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Months
    End point values
    Teriparatide Placebo
    Number of subjects analysed
    51
    51
    Units: units on a scale
        least squares mean (standard deviation)
    7.4 ± 4.02
    7.6 ± 3.87
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    B3D-MC-GHDN
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Screening
    Reporting group description
    -

    Reporting group title
    Placebo Acute
    Reporting group description
    -

    Reporting group title
    Teriparatide 20 mcg Acute
    Reporting group description
    -

    Reporting group title
    Placebo Follow-up
    Reporting group description
    -

    Reporting group title
    Teriparatide 20 mcg Follow-up
    Reporting group description
    -

    Serious adverse events
    Screening Placebo Acute Teriparatide 20 mcg Acute Placebo Follow-up Teriparatide 20 mcg Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 122 (0.00%)
    5 / 61 (8.20%)
    2 / 60 (3.33%)
    4 / 53 (7.55%)
    2 / 49 (4.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    wound
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    transitional cell carcinoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    bradyarrhythmia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    syncope
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    hepatitis toxic
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    bursitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fracture nonunion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    liver abscess
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Screening Placebo Acute Teriparatide 20 mcg Acute Placebo Follow-up Teriparatide 20 mcg Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 122 (31.97%)
    34 / 61 (55.74%)
    31 / 60 (51.67%)
    18 / 53 (33.96%)
    16 / 49 (32.65%)
    Vascular disorders
    haematoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    hypertension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    thrombosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Surgical and medical procedures
    cataract operation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    cholecystectomy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    sebaceous cyst excision
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 61 (3.28%)
    2 / 60 (3.33%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    device breakage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    facial pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    gait disturbance
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    oedema peripheral
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    pyrexia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    sense of oppression
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    thirst
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    behavioural and psychiatric symptoms of dementia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    depression
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    disorientation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    insomnia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 61 (3.28%)
    3 / 60 (5.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    3
    0
    0
    mental status changes
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    atrophic vulvovaginitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [1]
    0 / 88 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    prostatitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [2]
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 14 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [3]
    0 / 88 (0.00%)
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    bone contusion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    chest injury
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    contusion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    4
    1
    0
    excoriation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    femur fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    humerus fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    incision site complication
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    joint injury
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    0
    1
    laceration
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    spinal compression fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    tooth fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    Investigations
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    blood pressure increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    liver function test abnormal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    weight decreased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    aortic valve incompetence
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    arrhythmia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    palpitations
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    sinus tachycardia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    bronchiectasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    bronchitis chronic
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    cough
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    respiratory failure
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    carotid arteriosclerosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    dizziness
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    3 / 61 (4.92%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    1 / 49 (2.04%)
         occurrences all number
    0
    3
    1
    1
    1
    headache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    2 / 60 (3.33%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    neuralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    0
    1
    paraesthesia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    parkinson's disease
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    presyncope
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    syncope
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    tremor
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    vascular dementia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    vertebral artery stenosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    conjunctival haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    conjunctivitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    dacryostenosis acquired
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    glaucoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    macular degeneration
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    abdominal pain lower
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    constipation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    8 / 122 (6.56%)
    1 / 61 (1.64%)
    3 / 60 (5.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    8
    1
    3
    0
    1
    dental caries
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    diverticulum intestinal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    faecal incontinence
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    faecaloma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    0
    1
    gastritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    gastritis atrophic
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    gastritis erosive
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    gastrointestinal disorder
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    gingival swelling
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    haemorrhoids
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    hiatus hernia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    0
    1
    nausea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 61 (0.00%)
    2 / 60 (3.33%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    0
    2
    0
    1
    periodontal inflammation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    stomatitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    0
    1
    toothache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    pollakiuria
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    urinary retention
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    actinic keratosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    alopecia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    asteatosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    dermatitis contact
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    drug eruption
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    dyshidrotic eczema
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    erythema
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    hypertrophic scar
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    ingrowing nail
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    pruritus
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    rash
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    skin ulcer
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 61 (4.92%)
    3 / 60 (5.00%)
    0 / 53 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    1
    3
    3
    0
    3
    back pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    6 / 61 (9.84%)
    3 / 60 (5.00%)
    2 / 53 (3.77%)
    0 / 49 (0.00%)
         occurrences all number
    0
    6
    3
    2
    0
    chondropathy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    coccydynia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    flank pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    muscular weakness
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    myalgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 61 (1.64%)
    2 / 60 (3.33%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    neck pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    osteoarthritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    4 / 61 (6.56%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    osteonecrosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    0
    0
    0
    2
    osteoporosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    3 / 60 (5.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    spinal column stenosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    tenosynovitis stenosans
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    trigger finger
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Endocrine disorders
    hyperparathyroidism secondary
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    folate deficiency
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    hypercalcaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    hypoglycaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    malnutrition
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Infections and infestations
    adenoiditis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    0
    0
    0
    2
    cellulitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    cervicitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [4]
    0 / 88 (0.00%)
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    chronic hepatitis c
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    diverticulitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    ear infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    eye infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    gastroenteritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    helicobacter infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    influenza
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    laryngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    nail infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    3 / 61 (4.92%)
    4 / 60 (6.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    4
    5
    0
    0
    oral candidiasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    oral herpes
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    parotitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    pharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    rhinitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    skin infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    0
    0
    1
    tinea pedis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 61 (1.64%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 61 (3.28%)
    0 / 60 (0.00%)
    0 / 53 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    2
    0
    0
    1
    wound infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    1 / 60 (1.67%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    wound infection staphylococcal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 61 (0.00%)
    0 / 60 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2012
    The sponsor decided to end enrolment prematurely. The decision to stop enrolment was due to operational challenges and enrolment feasibility with regard to completing the study in a timely manner and not based on any safety or efficacy concerns in the trial. All active patients who were enrolled were offered to continue, and complete the study to 12 months.

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA