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Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00896532
Collaborator
(none)
419
Enrollment
8
Arms
80.5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study included a 24-month treatment phase followed by rerandomization to a 12-month extension phase with denosumab or placebo, followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention.

  • 24-month Romosozumab Treatment Phase (months 1 to 24): Participants were randomized in a 1:1:1:1:1:1:1:1 ratio to receive 1 of 5 double-blind dosing regimens of romosozumab or placebo or open-label alendronate (ALN) or open-label teriparatide (TPTD) for the first 12 months of the study. At month 12, participants in the romosozumab and placebo groups continued their assigned treatment for an additional 12 months, participants in the TPTD group ended study participation, and participants in the ALN group transitioned to receive romosozumab 140 mg subcutaneously (SC) every month (QM) for an additional 12 months (months 12 to 24).

  • 12-month Denosumab Extension Phase (months 24 to 36): At the end of the 24-month romosozumab treatment phase, eligible participants were randomized 1:1 within their original treatment group to receive either denosumab or placebo every 6 months (Q6M) for 12 months.

  • 12-month Romosozumab Retreatment Phase (months 36 to 48): From months 36 to 48, participants initially randomized to romosozumab or placebo received romosozumab 210 mg SC QM. Participants who initially received ALN ended their participation at month 36 and were not retreated with romosozumab.

  • 24-month Follow-on Phase (months 48 to 72): At month 48, participants received 1 dose of zoledronic acid 5 mg intravenously or no intervention for an additional 24 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
419 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Actual Study Start Date :
Jun 3, 2009
Actual Primary Completion Date :
Feb 21, 2011
Actual Study Completion Date :
Feb 18, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously (SC) for up to 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

Drug: Placebo to Romosozumab
Administered by subcutaneous injection QM or Q3M.

Drug: Denosumab
Denosumab 60 mg administered by subcutaneous injection Q6M
Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•
    Active Comparator: Alendronate

    Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. At month 36 participants ended study participation.

    Drug: Alendronate
    Administered orally once a week
    Other Names:
  • Fosamax

    • Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M
    Active Comparator: Teriparatide

    Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.

    Drug: Teriparatide
    Teriparatide 20 μg administered by subcutaneous injection once a day
    Other Names:
  • Forsteo

    		•
    Experimental: Romosozumab 70 mg QM

    Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

    Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•
    Experimental: Romosozumab 140 mg Q3M

    Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

    Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•
    Experimental: Romosozumab 140 mg QM

    Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

    Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•
    Experimental: Romosozumab 210 mg Q3M

    Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

    Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•
    Experimental: Romosozumab 210 mg QM

    Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.

    Drug: Romosozumab
    Administered by subcutaneous injection
    Other Names:
  • AMG 785
  • EVENITY™

    • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection Q6M
    Other Names:
  • Prolia®

    • Drug: Placebo to Denosumab
    Administered by subcutaneous injection Q6M

    Drug: Zoledronic acid
    Zoledronic acid 5 mg administered intravenously
    Other Names:
  • Aclasta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine [Baseline to 12 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.

    Secondary Outcome Measures

    1. Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine [Baseline to 6 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

    2. Percent Change From Baseline at Month 6 in BMD of the Total Hip [Baseline to 6 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

    3. Percent Change From Baseline at Month 6 in BMD of the Femoral Neck [Baseline to 6 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

    4. Percent Change From Baseline at Month 12 in BMD of the Total Hip [Baseline to 12 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

    5. Percent Change From Baseline at Month 12 in BMD of the Femoral Neck [Baseline to 12 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

    6. Percent Change From Baseline at Month 12 in BMD of the Distal Radius [Baseline to 12 months]

      Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables.

    7. Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) [Baseline and months 1, 3, 6, 9, and 12]

      Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

    8. Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) [Baseline and months 1, 3, 6, 9, and 12]

      Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

    9. Percent Change From Baseline in Osteocalcin [Baseline and months 1, 3, 6, 9, and 12]

      Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

    10. Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) [Baseline and months 1, 3, 6, 9, and 12]

      Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 85

    • Low BMD measured by dual energy X-ray absorptiometry (DXA) and assessed by the central imaging vendor (equivalent to T-scores between -2.0 and -3.5)

    Exclusion Criteria:

    • History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50

    • Untreated hyper- or hypothyroidism

    • Current hyper- or hypoparathyroidism, hypo- or hypercalcemia

    • Elevated transaminases

    • Significantly impaired renal function

    • Positive for: human immunodeficiency virus (HIV), hepatitis-C or hepatitis-B surface antigen

    • Malignancy

    • History of solid organ or bone marrow transplants

    • Use of agents affecting bone metabolism

    • Contraindicated or intolerant of alendronate therapy

    • Contraindicated or intolerant of teriparatide therapy

    Inclusion Criteria for the 12 month extension phase (Month 24 to 36):
    • Normocalcemia at or after the Month 21 visit but before the Month 24 study visit

    Exclusion Criteria for the 12 month extension phase (Month 24 to 36)

    • Incidence of a clinical vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis during the initial 24 month treatment phase of the study

    • A BMD loss of ≥ 7.0% from baseline at any time up to the Month 18 visit of the initial 24-month treatment phase

    • Malignancy

    • History of osteonecrosis of the jaw

    • Use of proscribed medication during the initial 24 month treatment phase

    • Contraindicated or intolerant of denosumab therapy

    Inclusion Criteria for the 12 month re-treatment phase (Month 36 to 48)

    • Albumin adjusted serum calcium of the most recent blood draw at or after the Month 30 visit but before the Month 36 study visit. Calcium repletion is permitted and central laboratory analysis of albumin adjusted serum calcium may be repeated before the Month 36 study visit

    • Participation in Group A or B during initial 24 month treatment phase

    • Subject has reached M36 of the study

    • Appropriate written informed consent must be obtained

    Exclusion Criteria for the 12 month re-treatment phase (Month 36 to 48)

    • New malignancy

    • Use of proscribed medication during the 12 month extension phase

    Inclusion Criteria for the 24 month follow-on phase (Month 48 to 72) General inclusion criteria for participation

    • Subject has reached month 48 of the study

    • Appropriate written informed consent must be obtained Inclusion criteria for assignment to the no intervention group

    • During the 24 month AMG 785 treatment phase, subject was assigned to any AMG 785 treatment group

    • During the 12 month denosumab extension phase, subject was assigned to the denosumab treatment group Exclusion for the 24 month follow-on phase (Month 48 to 72)

    • New malignancy

    • Use of proscribed meds during the 12 month re-treatment phase

    • Partial informed consent withdrawal and discontinuation of investigational product at any time up to month 48 visit

    • Incidence of a clinical vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis during the initial 24 month treatment phase of the study

    • BMD T-score of ≤ -2.5 at the lumbar spine, total hip, or femoral neck based on local read of the DXA scans at month 48

    • Intolerance to zoledronic acid

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT00896532
    Other Study ID Numbers:
    • 20060326
    • 2008-005991-28
    First Posted:
    May 11, 2009
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Bone Diseases, Metabolic
    Zoledronic Acid
    Denosumab
    Alendronate
    Teriparatide
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    Recruitment Details This study was conducted at 29 centers in 7 countries in Europe, North America, and Argentina. Participants were enrolled from the 3rd of June 2009 to the 17th of February 2010.
    Pre-assignment Detail A total of 807 patients were screened and 419 were randomized. The study included a 24-month treatment phase, followed by rerandomization to a 12-month extension phase with denosumab or placebo; followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM Month 24-36: Placebo/Placebo Month 24-36: Placebo/Denosumab Month 24-36: Alendronate/Romosozumab/Placebo Month 24-36: Alendronate/Romosozumab/Denosumab Month 24-36: Romosozumab/Placebo Month 24-36: Romosozumab/Denosumab Month 36-48: Placebo/Placebo/Romosozumab Month 36-48: Placebo/Denosumab/Romosozumab Month 36-48: Romosozumab/Placebo/Romosozumab Month 36-48: Romosozumab/Denosumab/Romosozumab Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months (Q6M) for 12 months during the denosumab extension phase. Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously QM from months 12 to 24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24-36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received placebo in the first 24 month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72). Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
    Period Title: Months 1-24: Romosozumab Treatment Phase
    STARTED 52 51 55 51 54 51 53 52 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Received Treatment 51 51 54 49 53 48 53 51 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Completed 12 Months 47 49 46 45 50 46 51 49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    COMPLETED 46 45 46 39 46 43 48 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 6 6 9 12 8 8 5 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Period Title: Months 1-24: Romosozumab Treatment Phase
    STARTED 0 0 0 0 0 0 0 0 18 18 20 21 93 90 0 0 0 0 0 0 0 0 0
    Received Treatment 0 0 0 0 0 0 0 0 18 18 19 19 90 88 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 17 18 18 19 88 88 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 1 0 2 2 5 2 0 0 0 0 0 0 0 0 0
    Period Title: Months 1-24: Romosozumab Treatment Phase
    STARTED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 16 72 67 0 0 0 0 0
    Received Romosozumab 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 16 72 67 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 14 65 64 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 7 3 0 0 0 0 0
    Period Title: Months 1-24: Romosozumab Treatment Phase
    STARTED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 51 11 12 59 8
    Received Zoledronic Acid 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 11 12 56 8
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 50 11 12 57 8
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 2 0

    Baseline Characteristics

    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM Total
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Total of all reporting groups
    Overall Participants 52 51 55 51 54 51 53 52 419
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.0
    (6.5)
    67.1
    (5.8)
    66.8
    (5.7)
    65.8
    (6.1)
    67.3
    (6.7)
    67.8
    (6.2)
    66.1
    (7.3)
    66.3
    (6.5)
    66.8
    (6.4)
    Age, Customized (Count of Participants)
    < 65 years
    20
    38.5%
    18
    35.3%
    21
    38.2%
    21
    41.2%
    20
    37%
    12
    23.5%
    24
    45.3%
    18
    34.6%
    154
    36.8%
    ≥ 65 years
    32
    61.5%
    33
    64.7%
    34
    61.8%
    30
    58.8%
    34
    63%
    39
    76.5%
    29
    54.7%
    34
    65.4%
    265
    63.2%
    Sex: Female, Male (Count of Participants)
    Female
    52
    100%
    51
    100%
    55
    100%
    51
    100%
    54
    100%
    51
    100%
    53
    100%
    52
    100%
    419
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White or Caucasian
    47
    90.4%
    46
    90.2%
    44
    80%
    46
    90.2%
    43
    79.6%
    48
    94.1%
    44
    83%
    44
    84.6%
    362
    86.4%
    Black or African American
    0
    0%
    0
    0%
    1
    1.8%
    0
    0%
    2
    3.7%
    0
    0%
    0
    0%
    0
    0%
    3
    0.7%
    Hispanic or Latino
    5
    9.6%
    4
    7.8%
    9
    16.4%
    5
    9.8%
    8
    14.8%
    3
    5.9%
    8
    15.1%
    6
    11.5%
    48
    11.5%
    Asian
    0
    0%
    1
    2%
    1
    1.8%
    0
    0%
    0
    0%
    0
    0%
    1
    1.9%
    1
    1.9%
    4
    1%
    Japanese
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.9%
    1
    0.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.9%
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    Lumbar Spine Bone Mineral Density (BMD) T-score (T-score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [T-score]
    -2.29
    (0.66)
    -2.08
    (0.69)
    -2.29
    (0.57)
    -2.35
    (0.79)
    -2.44
    (0.70)
    -2.27
    (0.77)
    -2.21
    (0.69)
    -2.33
    (0.57)
    -2.29
    (0.68)
    Total Hip BMD T-score (T-score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [T-score]
    -1.35
    (0.67)
    -1.55
    (0.68)
    -1.32
    (0.78)
    -1.69
    (0.67)
    -1.58
    (0.51)
    -1.67
    (0.65)
    -1.65
    (0.63)
    -1.45
    (0.65)
    -1.53
    (0.66)
    Femoral Neck BMD T-score (T-score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [T-score]
    -1.76
    (0.56)
    -1.91
    (0.61)
    -1.79
    (0.67)
    -2.06
    (0.55)
    -2.00
    (0.54)
    -2.03
    (0.58)
    -2.02
    (0.57)
    -1.87
    (0.58)
    -1.93
    (0.59)
    Distal 1/3 Radius BMD T-score (T-score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [T-score]
    -1.85
    (1.04)
    -2.08
    (0.99)
    -2.05
    (1.21)
    -1.78
    (1.14)
    -2.24
    (1.06)
    -2.11
    (1.12)
    -1.98
    (1.04)
    -2.03
    (0.99)
    -2.01
    (1.08)
    Serum Type 1 Collagen C-telopeptide (CTX) (ng/L) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [ng/L]
    481.0
    494.0
    505.5
    486.0
    525.0
    532.0
    478.0
    519.0
    501.5
    Serum Procollagen Type 1 N-telopeptide (P1NP) (μg/L) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [μg/L]
    47.76
    49.25
    48.78
    50.36
    48.63
    48.13
    49.24
    52.58
    49.37
    Osteocalcin (ng/mL) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [ng/mL]
    17.95
    19.37
    19.47
    19.03
    19.93
    18.56
    17.72
    18.36
    18.84
    Bone-specific Alkaline Phosphatase (BSAP) (μg/L) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [μg/L]
    11.79
    12.93
    13.34
    11.82
    13.19
    11.78
    12.61
    12.37
    12.44

    Outcome Measures

    1. Primary Outcome
    Title Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.
    Time Frame Baseline to 12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 12 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM Romosozumab Monthly Romosozumab Every 3 Months Romosozumab 140 mg Romosozumab 210 mg
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Participants who received once a month dosing of romosozumab (70, 140 or 210 mg). Participants who received romosozumab every 3 months (140 or 210 mg) Participants who received romosozumab 140 mg dosing (QM or Q3M). Participants who received romosozumab 210 mg dosing (QM or Q3M).
    Measure Participants 47 47 46 44 49 46 51 49 139 100 95 100
    Least Squares Mean (95% Confidence Interval) [percent change]
    -0.1
    4.1
    7.1
    5.4
    5.4
    9.1
    5.5
    11.3
    8.6
    5.5
    7.3
    8.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Romosozumab Monthly
    Comments A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments P-value is adjusted by the Hochberg procedure for comparisons to placebo.
    Method Linear Mixed Effects Model
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference from Placebo
    Estimated Value 8.7
    Confidence Interval (2-Sided) 95%
    7.5 to 9.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Romosozumab Every 3 Months
    Comments A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments P-value is adjusted by the Hochberg procedure for comparisons to placebo.
    Method Linear Mixed Effects Model
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference from placebo
    Estimated Value 5.6
    Confidence Interval (2-Sided) 95%
    4.3 to 6.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Romosozumab 140 mg
    Comments A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments P-value is adjusted by the Hochberg procedure for comparisons to placebo.
    Method Linear Mixed Effects Model
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference from Placebo
    Estimated Value 7.4
    Confidence Interval (2-Sided) 95%
    6.1 to 8.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Romosozumab 210 mg
    Comments A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments P-value is adjusted by the Hochberg procedure for comparisons to placebo.
    Method Linear Mixed Effects Model
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference from Placebo
    Estimated Value 8.5
    Confidence Interval (2-Sided) 95%
    7.3 to 9.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.
    Time Frame Baseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 6 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 49 49 48 43 49 47 52 50
    Least Squares Mean (95% Confidence Interval) [percent change]
    0.3
    2.6
    4.8
    4.1
    4.2
    7.1
    4.4
    8.2
    3. Secondary Outcome
    Title Percent Change From Baseline at Month 6 in BMD of the Total Hip
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.
    Time Frame Baseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 6 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 49 49 48 43 49 47 52 50
    Least Squares Mean (95% Confidence Interval) [percent change]
    -0.6
    0.9
    0.5
    0.5
    0.9
    2.2
    1.1
    2.9
    4. Secondary Outcome
    Title Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.
    Time Frame Baseline to 6 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 6 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 49 49 48 43 49 47 52 50
    Least Squares Mean (95% Confidence Interval) [percent change]
    -0.4
    0.5
    0.5
    0.2
    0.4
    2.1
    0.9
    1.9
    5. Secondary Outcome
    Title Percent Change From Baseline at Month 12 in BMD of the Total Hip
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.
    Time Frame Baseline to 12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 12 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 47 47 46 44 49 46 50 49
    Least Squares Mean (95% Confidence Interval) [percent change]
    -0.7
    1.9
    1.3
    1.3
    1.3
    3.4
    1.9
    4.1
    6. Secondary Outcome
    Title Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.
    Time Frame Baseline to 12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 12 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 47 47 46 44 49 46 50 49
    Least Squares Mean (95% Confidence Interval) [percent change]
    -1.1
    1.2
    1.1
    0.6
    1.8
    4.2
    1.4
    3.7
    7. Secondary Outcome
    Title Percent Change From Baseline at Month 12 in BMD of the Distal Radius
    Description Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables.
    Time Frame Baseline to 12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had non-missing baseline and month 12 measurements.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 48 46 42 44 48 46 49 46
    Least Squares Mean (95% Confidence Interval) [percent change]
    -0.9
    -0.3
    -1.7
    -1.8
    -1.1
    -1.0
    -0.4
    -1.2
    8. Secondary Outcome
    Title Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
    Description Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.
    Time Frame Baseline and months 1, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 50 51 49 49 53 48 53 50
    Month 1
    -0.7
    24.2
    61.4
    55.0
    75.8
    92.2
    Month 3
    -5.4
    -50.8
    97.1
    -9.1
    -15.5
    3.8
    -19.5
    25.6
    Month 6
    -5.9
    -57.0
    138.0
    -20.0
    -22.8
    -18.6
    -25.5
    6.9
    Month 9
    -10.6
    -60.8
    116.8
    -26.9
    -23.8
    -26.1
    -30.1
    -5.8
    Month 12
    -8.7
    -60.8
    98.3
    -23.0
    -23.3
    -31.2
    -29.7
    -17.2
    9. Secondary Outcome
    Title Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
    Description Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.
    Time Frame Baseline and months 1, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 50 51 49 49 53 48 53 50
    Month 1
    -3.9
    -22.1
    -19.2
    -35.4
    -33.0
    -28.5
    Month 3
    -2.4
    -65.0
    69.4
    -21.5
    -6.2
    -26.5
    -12.6
    -3.7
    Month 6
    2.7
    -64.2
    93.5
    -18.1
    -8.4
    -24.6
    -10.5
    -8.7
    Month 9
    1.0
    -64.4
    81.3
    -15.1
    1.3
    -27.7
    -11.7
    -17.2
    Month 12
    9.8
    -66.7
    77.0
    -20.3
    12.2
    -33.0
    -6.6
    -22.5
    10. Secondary Outcome
    Title Percent Change From Baseline in Osteocalcin
    Description Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.
    Time Frame Baseline and months 1, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 50 51 49 49 53 48 53 50
    Month 1
    -1.6
    28.1
    60.1
    53.1
    77.9
    78.6
    Month 3
    4.1
    -28.7
    104.7
    -0.3
    -5.6
    15.6
    -3.7
    41.6
    Month 6
    -7.1
    -40.6
    106.7
    -11.8
    -16.5
    -7.4
    -23.2
    10.0
    Month 9
    -6.0
    -50.9
    99.9
    -26.9
    -29.0
    -27.7
    -30.7
    -4.0
    Month 12
    -14.1
    -50.3
    91.6
    -27.3
    -24.7
    -31.1
    -26.2
    -12.5
    11. Secondary Outcome
    Title Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
    Description Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.
    Time Frame Baseline and months 1, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.
    Arm/Group Title Placebo Alendronate Teriparatide Romosozumab 70 mg QM Romosozumab 140 mg Q3M Romosozumab 140 mg QM Romosozumab 210 mg Q3M Romosozumab 210 mg QM
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.
    Measure Participants 50 51 49 49 53 48 53 50
    Month 1
    -1.1
    11.7
    35.1
    29.3
    47.5
    60.9
    Month 3
    -7.6
    -30.5
    21.8
    -8.5
    -18.0
    1.3
    -17.3
    27.4
    Month 6
    -4.1
    -35.4
    29.8
    -8.7
    -18.2
    -6.6
    -20.0
    13.1
    Month 9
    3.5
    -32.5
    41.8
    -4.9
    -12.5
    -5.5
    -17.7
    10.4
    Month 12
    9.2
    -31.2
    45.7
    -2.6
    -10.8
    -5.0
    -12.4
    9.2

    Adverse Events

    Time Frame Adverse events are reported by treatment phase: Romosozumab treatment phase (Baseline [BL] to month 12 and 24); Denosumab extension phase (months 24 to 36); Romosozumab retreatment phase (months 36 to 48); Follow-on phase (months 48 to 72).
    Adverse Event Reporting Description The safety subset is based on actual treatment received. One participant randomized to placebo received 1 dose of romosozumab 70 mg in error was subsequently randomized to denosumab and then received romosozumab in the retreatment phase. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed a 5% threshold
    Arm/Group Title BL-Month 12: Placebo QM BL-Month 12: Placebo Q3M BL-Month 12: Alendronate BL-Month12: Teriparatide BL-Month 12: Romosozumab 70 mg QM BL-Month 12: Romosozumab 140 mg Q3M BL-Month 12: Romosozumab 140 mg QM BL-Month 12: Romosozumab 210 mg Q3M BL-Month 12: Romosozumab 210 mg QM BL-Month 24: Placebo QM BL-Month 24: Placebo Q3M BL-Month 24: ALN/Romosozumab 140 mg QM BL-Month 24: Romosozumab 70 mg QM BL-Month 24: Romosozumab 140 mg Q3M BL-Month 24: Romosozumab 140 mg QM BL-Month 24: Romosozumab 210 mg Q3M BL-Month 24: Romosozumab 210 mg QM Month 24-36: Placebo/Placebo Month 24-36: Placebo/Denosumab Month 24-36: ALN/Romosozumab/Placebo Month 24-36: ALN/Romosozumab/Denosumab Month 24-36: Romosozumab/Placebo Month 24-36: Romosozumab/Denosumab Month 36-48: Placebo/Placebo/Romosozumab Month 36-48: Placebo/Denosumab/Romosozumab Month 36-48: Romosozumab/Placebo/Romosozumab Month 36-48: Romosozumab/Denosumab/Romosozumab Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention Month 48-72: Romosozumab/Placebo/Romosozumab/No Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid
    Arm/Group Description Participants received placebo matching to romosozumab once a month (QM) administered subcutaneously for 12 months. Participants received placebo matching to romosozumab once every 3 months (Q3M) administered subcutaneously for 12 months. Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. Participants received double-blind romosozumab 70 mg subcutaneously every month for 12 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 12 months. Participants received double-blind romosozumab 140 mg subcutaneously every month for 12 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 12 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 12 months. Participants received placebo matching to romosozumab QM administered subcutaneously for 24 months. Participants received placebo matching to romosozumab Q3M administered subcutaneously for 24 months. Participants received open-label alendronate (ALN) 70 mg PO QW for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants received double-blind romosozumab 140 mg subcutaneously every month for 24 months. Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously every month from months 12-24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received placebo in the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). Participants who received romosozumab at any dose during the first 24 month treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72). Participants who received romosozumab at any dose during the first 24 month treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 were assigned to the zoledronic acid treatment group, but received no intervention during the 24-month follow-on phase (months 48 to 72). Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.
    All Cause Mortality
    BL-Month 12: Placebo QM BL-Month 12: Placebo Q3M BL-Month 12: Alendronate BL-Month12: Teriparatide BL-Month 12: Romosozumab 70 mg QM BL-Month 12: Romosozumab 140 mg Q3M BL-Month 12: Romosozumab 140 mg QM BL-Month 12: Romosozumab 210 mg Q3M BL-Month 12: Romosozumab 210 mg QM BL-Month 24: Placebo QM BL-Month 24: Placebo Q3M BL-Month 24: ALN/Romosozumab 140 mg QM BL-Month 24: Romosozumab 70 mg QM BL-Month 24: Romosozumab 140 mg Q3M BL-Month 24: Romosozumab 140 mg QM BL-Month 24: Romosozumab 210 mg Q3M BL-Month 24: Romosozumab 210 mg QM Month 24-36: Placebo/Placebo Month 24-36: Placebo/Denosumab Month 24-36: ALN/Romosozumab/Placebo Month 24-36: ALN/Romosozumab/Denosumab Month 24-36: Romosozumab/Placebo Month 24-36: Romosozumab/Denosumab Month 36-48: Placebo/Placebo/Romosozumab Month 36-48: Placebo/Denosumab/Romosozumab Month 36-48: Romosozumab/Placebo/Romosozumab Month 36-48: Romosozumab/Denosumab/Romosozumab Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention Month 48-72: Romosozumab/Placebo/Romosozumab/No Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    BL-Month 12: Placebo QM BL-Month 12: Placebo Q3M BL-Month 12: Alendronate BL-Month12: Teriparatide BL-Month 12: Romosozumab 70 mg QM BL-Month 12: Romosozumab 140 mg Q3M BL-Month 12: Romosozumab 140 mg QM BL-Month 12: Romosozumab 210 mg Q3M BL-Month 12: Romosozumab 210 mg QM BL-Month 24: Placebo QM BL-Month 24: Placebo Q3M BL-Month 24: ALN/Romosozumab 140 mg QM BL-Month 24: Romosozumab 70 mg QM BL-Month 24: Romosozumab 140 mg Q3M BL-Month 24: Romosozumab 140 mg QM BL-Month 24: Romosozumab 210 mg Q3M BL-Month 24: Romosozumab 210 mg QM Month 24-36: Placebo/Placebo Month 24-36: Placebo/Denosumab Month 24-36: ALN/Romosozumab/Placebo Month 24-36: ALN/Romosozumab/Denosumab Month 24-36: Romosozumab/Placebo Month 24-36: Romosozumab/Denosumab Month 36-48: Placebo/Placebo/Romosozumab Month 36-48: Placebo/Denosumab/Romosozumab Month 36-48: Romosozumab/Placebo/Romosozumab Month 36-48: Romosozumab/Denosumab/Romosozumab Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention Month 48-72: Romosozumab/Placebo/Romosozumab/No Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/30 (10%) 4/20 (20%) 4/51 (7.8%) 5/54 (9.3%) 5/50 (10%) 3/52 (5.8%) 2/49 (4.1%) 3/53 (5.7%) 6/51 (11.8%) 5/30 (16.7%) 4/20 (20%) 8/51 (15.7%) 9/50 (18%) 8/52 (15.4%) 8/49 (16.3%) 6/53 (11.3%) 7/51 (13.7%) 2/18 (11.1%) 1/17 (5.9%) 2/19 (10.5%) 0/19 (0%) 3/90 (3.3%) 8/89 (9%) 0/12 (0%) 1/15 (6.7%) 4/72 (5.6%) 3/68 (4.4%) 8/51 (15.7%) 0/3 (0%) 1/11 (9.1%) 1/12 (8.3%) 9/56 (16.1%) 1/8 (12.5%)
    Blood and lymphatic system disorders
    Pancytopenia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Angina pectoris 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Angina unstable 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Atrial fibrillation 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Atrioventricular block second degree 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardiac failure congestive 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardiac tamponade 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardio-respiratory arrest 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Coronary artery disease 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Mitral valve stenosis 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Myocardial infarction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Sinus node dysfunction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Sinus tachycardia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Endocrine disorders
    Hyperparathyroidism 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Eye disorders
    Iridocyclitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Gastrointestinal disorders
    Abdominal pain upper 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Barrett's oesophagus 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Colitis ischaemic 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Diverticulum 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gastric ulcer 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gastrointestinal fistula 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gastrointestinal necrosis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Inguinal hernia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Intestinal obstruction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Irritable bowel syndrome 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Large intestine polyp 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nausea 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Peritoneal haemorrhage 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Small intestinal obstruction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vomiting 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    General disorders
    Asthenia 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Non-cardiac chest pain 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hepatobiliary disorders
    Bile duct stone 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cholangitis 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cholecystitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cholelithiasis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Immune system disorders
    Anaphylactic reaction 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Infections and infestations
    Abscess intestinal 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Appendicitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Appendicitis perforated 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Bronchitis 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Clostridium difficile colitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Diverticulitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Escherichia sepsis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gastroenteritis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Lung infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Mycobacterium kansasii infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pneumonia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 3/56 (5.4%) 0/8 (0%)
    Pneumonia legionella 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Salpingitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injury, poisoning and procedural complications
    Epicondylitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Fall 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Fibula fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Head injury 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Postoperative ileus 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Radius fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Tibia fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ulna fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Metabolism and nutrition disorders
    Central obesity 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dehydration 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Diabetes mellitus 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hyponatraemia 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ketoacidosis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Chondropathy 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Flank pain 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Foot deformity 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Intervertebral disc protrusion 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Musculoskeletal pain 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Osteoarthritis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Rotator cuff syndrome 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Anal cancer 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Breast cancer 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Colon adenoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Colon cancer 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Invasive ductal breast carcinoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Leiomyoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Lung neoplasm malignant 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Non-Hodgkin's lymphoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Renal neoplasm 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Renal oncocytoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Squamous cell carcinoma of lung 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Thyroid cancer 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Uterine cancer 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nervous system disorders
    Amnesia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cerebral haemorrhage 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cerebral ischaemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cerebrovascular accident 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Coma 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dementia Alzheimer's type 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Lacunar infarction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Loss of consciousness 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nerve compression 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Paraesthesia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Transient ischaemic attack 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tremor 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Psychiatric disorders
    Depression 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Renal and urinary disorders
    Haematuria 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nephrolithiasis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Stress urinary incontinence 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Reproductive system and breast disorders
    Hysterocele 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ovarian cyst 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Rectocele 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Uterine polyp 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Uterine prolapse 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Vaginal prolapse 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dyspnoea 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pleural effusion 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pulmonary embolism 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Respiratory distress 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vascular disorders
    Arteriosclerosis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Femoral artery occlusion 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hypertension 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    BL-Month 12: Placebo QM BL-Month 12: Placebo Q3M BL-Month 12: Alendronate BL-Month12: Teriparatide BL-Month 12: Romosozumab 70 mg QM BL-Month 12: Romosozumab 140 mg Q3M BL-Month 12: Romosozumab 140 mg QM BL-Month 12: Romosozumab 210 mg Q3M BL-Month 12: Romosozumab 210 mg QM BL-Month 24: Placebo QM BL-Month 24: Placebo Q3M BL-Month 24: ALN/Romosozumab 140 mg QM BL-Month 24: Romosozumab 70 mg QM BL-Month 24: Romosozumab 140 mg Q3M BL-Month 24: Romosozumab 140 mg QM BL-Month 24: Romosozumab 210 mg Q3M BL-Month 24: Romosozumab 210 mg QM Month 24-36: Placebo/Placebo Month 24-36: Placebo/Denosumab Month 24-36: ALN/Romosozumab/Placebo Month 24-36: ALN/Romosozumab/Denosumab Month 24-36: Romosozumab/Placebo Month 24-36: Romosozumab/Denosumab Month 36-48: Placebo/Placebo/Romosozumab Month 36-48: Placebo/Denosumab/Romosozumab Month 36-48: Romosozumab/Placebo/Romosozumab Month 36-48: Romosozumab/Denosumab/Romosozumab Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention Month 48-72: Romosozumab/Placebo/Romosozumab/No Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/30 (83.3%) 19/20 (95%) 38/51 (74.5%) 36/54 (66.7%) 46/50 (92%) 40/52 (76.9%) 41/49 (83.7%) 45/53 (84.9%) 40/51 (78.4%) 28/30 (93.3%) 20/20 (100%) 49/51 (96.1%) 48/50 (96%) 47/52 (90.4%) 46/49 (93.9%) 51/53 (96.2%) 47/51 (92.2%) 15/18 (83.3%) 15/17 (88.2%) 12/19 (63.2%) 15/19 (78.9%) 57/90 (63.3%) 59/89 (66.3%) 12/12 (100%) 11/15 (73.3%) 53/72 (73.6%) 55/68 (80.9%) 34/51 (66.7%) 1/3 (33.3%) 10/11 (90.9%) 8/12 (66.7%) 44/56 (78.6%) 7/8 (87.5%)
    Blood and lymphatic system disorders
    Normochromic normocytic anaemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardiac disorders
    Angina pectoris 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Palpitations 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 0/50 (0%) 1/52 (1.9%) 2/49 (4.1%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 1/52 (1.9%) 3/49 (6.1%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 2/72 (2.8%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Ventricular extrasystoles 0/30 (0%) 1/20 (5%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ear and labyrinth disorders
    Deafness neurosensory 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Presbyacusis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Tinnitus 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vertigo 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 2/52 (3.8%) 1/49 (2%) 3/53 (5.7%) 2/51 (3.9%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 3/52 (5.8%) 2/49 (4.1%) 3/53 (5.7%) 5/51 (9.8%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Vertigo positional 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Endocrine disorders
    Goitre 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Eye disorders
    Age-related macular degeneration 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cataract 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/54 (3.7%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 5/53 (9.4%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 2/50 (4%) 1/52 (1.9%) 2/49 (4.1%) 5/53 (9.4%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 3/90 (3.3%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 1/72 (1.4%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Dacryostenosis acquired 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 2/52 (3.8%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 2/52 (3.8%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Dry eye 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 2/53 (3.8%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vision blurred 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Visual acuity reduced 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Vitreous floaters 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 3/50 (6%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Abdominal distension 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Abdominal pain 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 3/50 (6%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 0/20 (0%) 3/51 (5.9%) 4/50 (8%) 2/52 (3.8%) 1/49 (2%) 2/53 (3.8%) 4/51 (7.8%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Abdominal pain upper 1/30 (3.3%) 1/20 (5%) 2/51 (3.9%) 0/54 (0%) 4/50 (8%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 1/20 (5%) 4/51 (7.8%) 4/50 (8%) 0/52 (0%) 3/49 (6.1%) 3/53 (5.7%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 3/72 (4.2%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Constipation 3/30 (10%) 0/20 (0%) 3/51 (5.9%) 2/54 (3.7%) 5/50 (10%) 2/52 (3.8%) 5/49 (10.2%) 5/53 (9.4%) 2/51 (3.9%) 3/30 (10%) 0/20 (0%) 4/51 (7.8%) 6/50 (12%) 3/52 (5.8%) 5/49 (10.2%) 5/53 (9.4%) 2/51 (3.9%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Diaphragmatic hernia 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Diarrhoea 2/30 (6.7%) 2/20 (10%) 2/51 (3.9%) 1/54 (1.9%) 3/50 (6%) 2/52 (3.8%) 4/49 (8.2%) 0/53 (0%) 0/51 (0%) 3/30 (10%) 2/20 (10%) 3/51 (5.9%) 5/50 (10%) 3/52 (5.8%) 4/49 (8.2%) 2/53 (3.8%) 0/51 (0%) 1/18 (5.6%) 1/17 (5.9%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 2/12 (16.7%) 0/15 (0%) 2/72 (2.8%) 5/68 (7.4%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 3/56 (5.4%) 0/8 (0%)
    Diverticulum 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Diverticulum intestinal 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 3/51 (5.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dry mouth 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 1/19 (5.3%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dyspepsia 2/30 (6.7%) 1/20 (5%) 2/51 (3.9%) 3/54 (5.6%) 4/50 (8%) 0/52 (0%) 1/49 (2%) 3/53 (5.7%) 0/51 (0%) 2/30 (6.7%) 1/20 (5%) 3/51 (5.9%) 6/50 (12%) 0/52 (0%) 1/49 (2%) 5/53 (9.4%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 1/90 (1.1%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Gastritis 0/30 (0%) 2/20 (10%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 2/52 (3.8%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 2/20 (10%) 0/51 (0%) 1/50 (2%) 4/52 (7.7%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 1/8 (12.5%)
    Gastrooesophageal reflux disease 1/30 (3.3%) 2/20 (10%) 1/51 (2%) 2/54 (3.7%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 2/20 (10%) 1/51 (2%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 2/56 (3.6%) 1/8 (12.5%)
    Haematochezia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Haemorrhoids 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 2/51 (3.9%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 3/51 (5.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Haemorrhoids thrombosed 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Large intestine polyp 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nausea 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 5/54 (9.3%) 9/50 (18%) 1/52 (1.9%) 3/49 (6.1%) 0/53 (0%) 0/51 (0%) 3/30 (10%) 0/20 (0%) 0/51 (0%) 9/50 (18%) 1/52 (1.9%) 4/49 (8.2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 3/68 (4.4%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 3/56 (5.4%) 0/8 (0%)
    Paraesthesia oral 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Toothache 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 3/30 (10%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 2/68 (2.9%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 1/8 (12.5%)
    Vomiting 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 5/50 (10%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 1/30 (3.3%) 1/20 (5%) 2/51 (3.9%) 6/50 (12%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 3/68 (4.4%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    General disorders
    Asthenia 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 1/56 (1.8%) 0/8 (0%)
    Discomfort 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Facial pain 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Fatigue 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 4/50 (8%) 1/52 (1.9%) 5/49 (10.2%) 1/53 (1.9%) 2/51 (3.9%) 1/30 (3.3%) 1/20 (5%) 6/51 (11.8%) 6/50 (12%) 1/52 (1.9%) 7/49 (14.3%) 1/53 (1.9%) 2/51 (3.9%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 3/56 (5.4%) 0/8 (0%)
    Gait disturbance 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Influenza like illness 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 2/52 (3.8%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 2/50 (4%) 2/52 (3.8%) 0/49 (0%) 1/53 (1.9%) 3/51 (5.9%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 3/11 (27.3%) 2/12 (16.7%) 9/56 (16.1%) 0/8 (0%)
    Injection site bruising 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 3/50 (6%) 1/52 (1.9%) 3/49 (6.1%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 3/50 (6%) 1/52 (1.9%) 4/49 (8.2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site erythema 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 2/50 (4%) 1/52 (1.9%) 2/49 (4.1%) 1/53 (1.9%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 1/52 (1.9%) 2/49 (4.1%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site haematoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site pain 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 3/50 (6%) 2/52 (3.8%) 4/49 (8.2%) 4/53 (7.5%) 3/51 (5.9%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 4/50 (8%) 3/52 (5.8%) 5/49 (10.2%) 5/53 (9.4%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 2/15 (13.3%) 2/72 (2.8%) 3/68 (4.4%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site pruritus 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 1/72 (1.4%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site reaction 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injection site urticaria 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Malaise 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Oedema peripheral 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 2/49 (4.1%) 2/53 (3.8%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 3/51 (5.9%) 3/50 (6%) 0/52 (0%) 2/49 (4.1%) 2/53 (3.8%) 0/51 (0%) 2/18 (11.1%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Pain 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Peripheral swelling 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 2/49 (4.1%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 2/89 (2.2%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pyrexia 0/30 (0%) 1/20 (5%) 0/51 (0%) 1/54 (1.9%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 2/50 (4%) 2/52 (3.8%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Hepatobiliary disorders
    Drug-induced liver injury 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Immune system disorders
    Drug hypersensitivity 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Infections and infestations
    Borrelia infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Bronchitis 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 2/54 (3.7%) 5/50 (10%) 5/52 (9.6%) 3/49 (6.1%) 1/53 (1.9%) 2/51 (3.9%) 2/30 (6.7%) 2/20 (10%) 6/51 (11.8%) 6/50 (12%) 5/52 (9.6%) 5/49 (10.2%) 3/53 (5.7%) 4/51 (7.8%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 2/19 (10.5%) 1/90 (1.1%) 1/89 (1.1%) 2/12 (16.7%) 2/15 (13.3%) 2/72 (2.8%) 2/68 (2.9%) 3/51 (5.9%) 0/3 (0%) 1/11 (9.1%) 2/12 (16.7%) 3/56 (5.4%) 0/8 (0%)
    Conjunctivitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 1/51 (2%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cystitis 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 3/50 (6%) 0/52 (0%) 2/49 (4.1%) 2/53 (3.8%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 3/51 (5.9%) 6/50 (12%) 0/52 (0%) 3/49 (6.1%) 3/53 (5.7%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 2/19 (10.5%) 5/90 (5.6%) 1/89 (1.1%) 2/12 (16.7%) 0/15 (0%) 3/72 (4.2%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 4/56 (7.1%) 0/8 (0%)
    Diverticulitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 1/56 (1.8%) 0/8 (0%)
    Erysipelas 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Erythema migrans 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Eye infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 1/51 (2%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gastroenteritis 2/30 (6.7%) 1/20 (5%) 2/51 (3.9%) 1/54 (1.9%) 3/50 (6%) 2/52 (3.8%) 4/49 (8.2%) 5/53 (9.4%) 8/51 (15.7%) 2/30 (6.7%) 1/20 (5%) 4/51 (7.8%) 4/50 (8%) 2/52 (3.8%) 4/49 (8.2%) 5/53 (9.4%) 9/51 (17.6%) 1/18 (5.6%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 4/56 (7.1%) 0/8 (0%)
    Gastroenteritis viral 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 2/72 (2.8%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Gingival abscess 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gingivitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Helicobacter infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 3/53 (5.7%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 3/53 (5.7%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Herpes ophthalmic 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Herpes zoster 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hordeolum 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Influenza 2/30 (6.7%) 2/20 (10%) 3/51 (5.9%) 3/54 (5.6%) 2/50 (4%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 4/51 (7.8%) 5/30 (16.7%) 3/20 (15%) 10/51 (19.6%) 7/50 (14%) 3/52 (5.8%) 4/49 (8.2%) 5/53 (9.4%) 8/51 (15.7%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 1/19 (5.3%) 2/90 (2.2%) 4/89 (4.5%) 3/12 (25%) 1/15 (6.7%) 8/72 (11.1%) 7/68 (10.3%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 2/12 (16.7%) 8/56 (14.3%) 1/8 (12.5%)
    Laryngitis 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 2/54 (3.7%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Localised infection 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 2/49 (4.1%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Mastitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nail infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nasopharyngitis 4/30 (13.3%) 3/20 (15%) 3/51 (5.9%) 4/54 (7.4%) 19/50 (38%) 10/52 (19.2%) 13/49 (26.5%) 5/53 (9.4%) 9/51 (17.6%) 8/30 (26.7%) 4/20 (20%) 10/51 (19.6%) 20/50 (40%) 14/52 (26.9%) 17/49 (34.7%) 10/53 (18.9%) 14/51 (27.5%) 1/18 (5.6%) 1/17 (5.9%) 3/19 (15.8%) 4/19 (21.1%) 7/90 (7.8%) 10/89 (11.2%) 3/12 (25%) 3/15 (20%) 8/72 (11.1%) 11/68 (16.2%) 4/51 (7.8%) 0/3 (0%) 2/11 (18.2%) 2/12 (16.7%) 4/56 (7.1%) 2/8 (25%)
    Onychomycosis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Oral fungal infection 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 1/3 (33.3%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Oral herpes 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 1/15 (6.7%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Periodontitis 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pharyngitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 1/52 (1.9%) 3/49 (6.1%) 2/53 (3.8%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pharyngitis streptococcal 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pneumonia 0/30 (0%) 2/20 (10%) 0/51 (0%) 1/54 (1.9%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 2/20 (10%) 1/51 (2%) 2/50 (4%) 2/52 (3.8%) 4/49 (8.2%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 2/19 (10.5%) 1/19 (5.3%) 1/90 (1.1%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 3/72 (4.2%) 3/68 (4.4%) 2/51 (3.9%) 0/3 (0%) 2/11 (18.2%) 0/12 (0%) 2/56 (3.6%) 0/8 (0%)
    Pneumonia viral 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Post procedural infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Pulpitis dental 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Respiratory tract infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 1/3 (33.3%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Rhinitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 2/49 (4.1%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 4/49 (8.2%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Sinusitis 1/30 (3.3%) 1/20 (5%) 1/51 (2%) 0/54 (0%) 3/50 (6%) 0/52 (0%) 2/49 (4.1%) 2/53 (3.8%) 2/51 (3.9%) 1/30 (3.3%) 2/20 (10%) 3/51 (5.9%) 7/50 (14%) 2/52 (3.8%) 4/49 (8.2%) 6/53 (11.3%) 7/51 (13.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 3/89 (3.4%) 0/12 (0%) 0/15 (0%) 3/72 (4.2%) 0/68 (0%) 1/51 (2%) 1/3 (33.3%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tooth abscess 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/54 (3.7%) 0/50 (0%) 0/52 (0%) 3/49 (6.1%) 0/53 (0%) 3/51 (5.9%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 3/49 (6.1%) 1/53 (1.9%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tooth infection 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 2/51 (3.9%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 1/3 (33.3%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tracheitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Upper respiratory tract infection 1/30 (3.3%) 0/20 (0%) 2/51 (3.9%) 1/54 (1.9%) 4/50 (8%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 6/51 (11.8%) 2/30 (6.7%) 0/20 (0%) 3/51 (5.9%) 7/50 (14%) 3/52 (5.8%) 3/49 (6.1%) 2/53 (3.8%) 8/51 (15.7%) 1/18 (5.6%) 2/17 (11.8%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 4/72 (5.6%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 1/8 (12.5%)
    Urinary tract infection 0/30 (0%) 0/20 (0%) 4/51 (7.8%) 3/54 (5.6%) 0/50 (0%) 3/52 (5.8%) 3/49 (6.1%) 5/53 (9.4%) 5/51 (9.8%) 3/30 (10%) 0/20 (0%) 7/51 (13.7%) 5/50 (10%) 4/52 (7.7%) 4/49 (8.2%) 9/53 (17%) 6/51 (11.8%) 0/18 (0%) 1/17 (5.9%) 1/19 (5.3%) 0/19 (0%) 5/90 (5.6%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 4/72 (5.6%) 1/68 (1.5%) 6/51 (11.8%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 1/8 (12.5%)
    Vestibular neuronitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Viral infection 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Viral sinusitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Viral upper respiratory tract infection 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 4/90 (4.4%) 3/89 (3.4%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vulvovaginal mycotic infection 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Arthropod bite 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 3/72 (4.2%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Arthropod sting 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Chest injury 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Contusion 4/30 (13.3%) 0/20 (0%) 2/51 (3.9%) 1/54 (1.9%) 3/50 (6%) 5/52 (9.6%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 4/30 (13.3%) 0/20 (0%) 2/51 (3.9%) 4/50 (8%) 5/52 (9.6%) 3/49 (6.1%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 1/19 (5.3%) 1/90 (1.1%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Eye contusion 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Fall 1/30 (3.3%) 0/20 (0%) 4/51 (7.8%) 1/54 (1.9%) 2/50 (4%) 3/52 (5.8%) 2/49 (4.1%) 1/53 (1.9%) 1/51 (2%) 2/30 (6.7%) 0/20 (0%) 7/51 (13.7%) 4/50 (8%) 3/52 (5.8%) 7/49 (14.3%) 3/53 (5.7%) 4/51 (7.8%) 1/18 (5.6%) 0/17 (0%) 1/19 (5.3%) 1/19 (5.3%) 3/90 (3.3%) 4/89 (4.5%) 0/12 (0%) 1/15 (6.7%) 3/72 (4.2%) 4/68 (5.9%) 0/51 (0%) 1/3 (33.3%) 0/11 (0%) 0/12 (0%) 4/56 (7.1%) 2/8 (25%)
    Foot fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/54 (3.7%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Joint injury 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Laceration 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 1/51 (2%) 2/50 (4%) 0/52 (0%) 4/49 (8.2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ligament rupture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ligament sprain 0/30 (0%) 1/20 (5%) 1/51 (2%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 3/51 (5.9%) 1/30 (3.3%) 1/20 (5%) 1/51 (2%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 1/12 (8.3%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Post procedural contusion 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Post procedural haematoma 2/30 (6.7%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 2/30 (6.7%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Post procedural haemorrhage 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Procedural pain 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 2/50 (4%) 3/52 (5.8%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 2/30 (6.7%) 0/20 (0%) 2/51 (3.9%) 4/50 (8%) 6/52 (11.5%) 0/49 (0%) 1/53 (1.9%) 4/51 (7.8%) 2/18 (11.1%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 2/68 (2.9%) 4/51 (7.8%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 2/56 (3.6%) 0/8 (0%)
    Radius fracture 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 2/50 (4%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 2/90 (2.2%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Rib fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Skin abrasion 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Thermal burn 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tooth fracture 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Wound 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Investigations
    Blood calcium increased 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Blood parathyroid hormone increased 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Blood potassium decreased 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Blood urine present 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Cardiac murmur 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Weight decreased 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 2/52 (3.8%) 0/49 (0%) 1/53 (1.9%) 3/51 (5.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Weight increased 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Gout 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hypercalcaemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hypercholesterolaemia 2/30 (6.7%) 0/20 (0%) 2/51 (3.9%) 2/54 (3.7%) 2/50 (4%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 2/51 (3.9%) 2/30 (6.7%) 1/20 (5%) 3/51 (5.9%) 3/50 (6%) 1/52 (1.9%) 3/49 (6.1%) 1/53 (1.9%) 4/51 (7.8%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hyperglycaemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Hyponatraemia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Insulin resistance 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Type 2 diabetes mellitus 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/30 (10%) 0/20 (0%) 4/51 (7.8%) 5/54 (9.3%) 8/50 (16%) 7/52 (13.5%) 6/49 (12.2%) 5/53 (9.4%) 2/51 (3.9%) 8/30 (26.7%) 3/20 (15%) 11/51 (21.6%) 10/50 (20%) 8/52 (15.4%) 6/49 (12.2%) 9/53 (17%) 6/51 (11.8%) 1/18 (5.6%) 0/17 (0%) 1/19 (5.3%) 3/19 (15.8%) 2/90 (2.2%) 6/89 (6.7%) 2/12 (16.7%) 0/15 (0%) 6/72 (8.3%) 11/68 (16.2%) 1/51 (2%) 1/3 (33.3%) 1/11 (9.1%) 0/12 (0%) 8/56 (14.3%) 2/8 (25%)
    Arthritis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 3/50 (6%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Back pain 2/30 (6.7%) 2/20 (10%) 6/51 (11.8%) 3/54 (5.6%) 4/50 (8%) 4/52 (7.7%) 7/49 (14.3%) 7/53 (13.2%) 3/51 (5.9%) 7/30 (23.3%) 2/20 (10%) 12/51 (23.5%) 8/50 (16%) 8/52 (15.4%) 12/49 (24.5%) 9/53 (17%) 5/51 (9.8%) 1/18 (5.6%) 1/17 (5.9%) 1/19 (5.3%) 2/19 (10.5%) 1/90 (1.1%) 4/89 (4.5%) 2/12 (16.7%) 0/15 (0%) 6/72 (8.3%) 8/68 (11.8%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Bursitis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Costochondritis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Exostosis 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Intervertebral disc degeneration 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Knee deformity 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Muscle spasms 0/30 (0%) 0/20 (0%) 1/51 (2%) 8/54 (14.8%) 0/50 (0%) 2/52 (3.8%) 1/49 (2%) 0/53 (0%) 3/51 (5.9%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 4/52 (7.7%) 1/49 (2%) 0/53 (0%) 4/51 (7.8%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 3/89 (3.4%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Musculoskeletal chest pain 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 0/54 (0%) 1/50 (2%) 2/52 (3.8%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 2/51 (3.9%) 2/50 (4%) 2/52 (3.8%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Musculoskeletal pain 2/30 (6.7%) 0/20 (0%) 2/51 (3.9%) 2/54 (3.7%) 4/50 (8%) 2/52 (3.8%) 2/49 (4.1%) 3/53 (5.7%) 1/51 (2%) 3/30 (10%) 0/20 (0%) 3/51 (5.9%) 8/50 (16%) 3/52 (5.8%) 2/49 (4.1%) 4/53 (7.5%) 2/51 (3.9%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 1/90 (1.1%) 2/89 (2.2%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 4/68 (5.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 2/8 (25%)
    Musculoskeletal stiffness 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 1/51 (2%) 4/50 (8%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Myalgia 2/30 (6.7%) 1/20 (5%) 1/51 (2%) 1/54 (1.9%) 2/50 (4%) 0/52 (0%) 1/49 (2%) 2/53 (3.8%) 1/51 (2%) 4/30 (13.3%) 2/20 (10%) 3/51 (5.9%) 3/50 (6%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 3/19 (15.8%) 0/90 (0%) 2/89 (2.2%) 0/12 (0%) 1/15 (6.7%) 2/72 (2.8%) 4/68 (5.9%) 0/51 (0%) 1/3 (33.3%) 0/11 (0%) 3/12 (25%) 7/56 (12.5%) 2/8 (25%)
    Neck mass 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Neck pain 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 2/50 (4%) 2/52 (3.8%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 3/51 (5.9%) 2/50 (4%) 2/52 (3.8%) 2/49 (4.1%) 1/53 (1.9%) 4/51 (7.8%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Osteoarthritis 3/30 (10%) 1/20 (5%) 2/51 (3.9%) 1/54 (1.9%) 1/50 (2%) 2/52 (3.8%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 5/30 (16.7%) 1/20 (5%) 5/51 (9.8%) 2/50 (4%) 6/52 (11.5%) 3/49 (6.1%) 5/53 (9.4%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 3/89 (3.4%) 1/12 (8.3%) 1/15 (6.7%) 2/72 (2.8%) 1/68 (1.5%) 3/51 (5.9%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 5/56 (8.9%) 1/8 (12.5%)
    Pain in extremity 3/30 (10%) 0/20 (0%) 2/51 (3.9%) 5/54 (9.3%) 10/50 (20%) 7/52 (13.5%) 5/49 (10.2%) 3/53 (5.7%) 6/51 (11.8%) 4/30 (13.3%) 0/20 (0%) 3/51 (5.9%) 12/50 (24%) 8/52 (15.4%) 6/49 (12.2%) 5/53 (9.4%) 6/51 (11.8%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 3/89 (3.4%) 1/12 (8.3%) 2/15 (13.3%) 4/72 (5.6%) 2/68 (2.9%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 1/12 (8.3%) 4/56 (7.1%) 1/8 (12.5%)
    Synovial cyst 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Temporomandibular joint syndrome 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Tendon disorder 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tendonitis 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 2/49 (4.1%) 1/53 (1.9%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 2/51 (3.9%) 1/50 (2%) 0/52 (0%) 4/49 (8.2%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Thoracic spine flattening 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Benign neoplasm of thyroid gland 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Haemangioma of liver 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Lipoma 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nervous system disorders
    Carotid artery occlusion 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dizziness 2/30 (6.7%) 1/20 (5%) 2/51 (3.9%) 5/54 (9.3%) 3/50 (6%) 3/52 (5.8%) 1/49 (2%) 1/53 (1.9%) 2/51 (3.9%) 3/30 (10%) 2/20 (10%) 4/51 (7.8%) 4/50 (8%) 6/52 (11.5%) 1/49 (2%) 2/53 (3.8%) 4/51 (7.8%) 2/18 (11.1%) 3/17 (17.6%) 0/19 (0%) 1/19 (5.3%) 1/90 (1.1%) 2/89 (2.2%) 0/12 (0%) 2/15 (13.3%) 3/72 (4.2%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Facial neuralgia 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Headache 5/30 (16.7%) 3/20 (15%) 3/51 (5.9%) 3/54 (5.6%) 3/50 (6%) 7/52 (13.5%) 3/49 (6.1%) 3/53 (5.7%) 5/51 (9.8%) 5/30 (16.7%) 3/20 (15%) 6/51 (11.8%) 5/50 (10%) 8/52 (15.4%) 3/49 (6.1%) 4/53 (7.5%) 7/51 (13.7%) 0/18 (0%) 1/17 (5.9%) 1/19 (5.3%) 1/19 (5.3%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 4/56 (7.1%) 1/8 (12.5%)
    Hypoaesthesia 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 2/50 (4%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Migraine 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 2/49 (4.1%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Nystagmus 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Paraesthesia 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 2/50 (4%) 3/52 (5.8%) 0/49 (0%) 0/53 (0%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Restless legs syndrome 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Sciatica 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 2/50 (4%) 1/52 (1.9%) 1/49 (2%) 2/53 (3.8%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 3/51 (5.9%) 5/50 (10%) 3/52 (5.8%) 1/49 (2%) 5/53 (9.4%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 3/72 (4.2%) 2/68 (2.9%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 3/56 (5.4%) 0/8 (0%)
    Somnolence 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tremor 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Psychiatric disorders
    Anxiety 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 2/30 (6.7%) 0/20 (0%) 2/51 (3.9%) 2/50 (4%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 2/51 (3.9%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 1/12 (8.3%) 1/15 (6.7%) 0/72 (0%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Depression 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 3/51 (5.9%) 1/50 (2%) 1/52 (1.9%) 0/49 (0%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Disorientation 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Insomnia 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 4/50 (8%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 3/51 (5.9%) 4/50 (8%) 1/52 (1.9%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 2/89 (2.2%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Renal and urinary disorders
    Hypercalciuria 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Pollakiuria 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Renal cyst 0/30 (0%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 2/50 (4%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 1/51 (2%) 2/50 (4%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Renal failure 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Renal impairment 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Reproductive system and breast disorders
    Breast calcifications 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Ovarian cyst 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Vulvovaginal dryness 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/54 (1.9%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 3/50 (6%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 2/30 (6.7%) 0/20 (0%) 4/51 (7.8%) 0/54 (0%) 8/50 (16%) 3/52 (5.8%) 4/49 (8.2%) 1/53 (1.9%) 5/51 (9.8%) 3/30 (10%) 1/20 (5%) 6/51 (11.8%) 8/50 (16%) 5/52 (9.6%) 8/49 (16.3%) 3/53 (5.7%) 8/51 (15.7%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 1/19 (5.3%) 3/90 (3.3%) 4/89 (4.5%) 2/12 (16.7%) 0/15 (0%) 3/72 (4.2%) 3/68 (4.4%) 3/51 (5.9%) 0/3 (0%) 1/11 (9.1%) 2/12 (16.7%) 4/56 (7.1%) 0/8 (0%)
    Epistaxis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 1/51 (2%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 2/90 (2.2%) 2/89 (2.2%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 1/68 (1.5%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Oropharyngeal pain 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 2/54 (3.7%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 1/53 (1.9%) 2/51 (3.9%) 0/18 (0%) 2/17 (11.8%) 1/19 (5.3%) 1/19 (5.3%) 0/90 (0%) 1/89 (1.1%) 1/12 (8.3%) 0/15 (0%) 2/72 (2.8%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Rhinitis allergic 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Skin and subcutaneous tissue disorders
    Cutaneous lupus erythematosus 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dermal cyst 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Dermatitis contact 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Eczema 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 3/50 (6%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 4/50 (8%) 1/52 (1.9%) 0/49 (0%) 2/53 (3.8%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 2/72 (2.8%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Erythema 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Night sweats 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Petechiae 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Pruritus 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 4/50 (8%) 0/52 (0%) 2/49 (4.1%) 1/53 (1.9%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 2/51 (3.9%) 4/50 (8%) 1/52 (1.9%) 2/49 (4.1%) 2/53 (3.8%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 1/90 (1.1%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 5/72 (6.9%) 2/68 (2.9%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 1/56 (1.8%) 0/8 (0%)
    Rash 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 0/52 (0%) 2/49 (4.1%) 1/53 (1.9%) 2/51 (3.9%) 2/18 (11.1%) 1/17 (5.9%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 2/89 (2.2%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 3/68 (4.4%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Rash pruritic 1/30 (3.3%) 0/20 (0%) 1/51 (2%) 0/54 (0%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 2/30 (6.7%) 0/20 (0%) 1/51 (2%) 2/50 (4%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 1/89 (1.1%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Skin lesion 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Surgical and medical procedures
    Endodontic procedure 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Intraocular lens implant 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Tooth extraction 1/30 (3.3%) 1/20 (5%) 1/51 (2%) 0/54 (0%) 1/50 (2%) 0/52 (0%) 1/49 (2%) 0/53 (0%) 0/51 (0%) 1/30 (3.3%) 1/20 (5%) 1/51 (2%) 1/50 (2%) 0/52 (0%) 2/49 (4.1%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 1/56 (1.8%) 0/8 (0%)
    Tooth repair 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Vascular disorders
    Deep vein thrombosis 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Haematoma 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 2/52 (3.8%) 1/49 (2%) 0/53 (0%) 2/51 (3.9%) 0/30 (0%) 0/20 (0%) 2/51 (3.9%) 1/50 (2%) 2/52 (3.8%) 3/49 (6.1%) 1/53 (1.9%) 2/51 (3.9%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 1/72 (1.4%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hypertension 1/30 (3.3%) 3/20 (15%) 1/51 (2%) 2/54 (3.7%) 3/50 (6%) 2/52 (3.8%) 2/49 (4.1%) 1/53 (1.9%) 2/51 (3.9%) 1/30 (3.3%) 3/20 (15%) 1/51 (2%) 4/50 (8%) 4/52 (7.7%) 6/49 (12.2%) 3/53 (5.7%) 4/51 (7.8%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 4/90 (4.4%) 3/89 (3.4%) 2/12 (16.7%) 1/15 (6.7%) 3/72 (4.2%) 6/68 (8.8%) 1/51 (2%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 1/8 (12.5%)
    Hypertensive crisis 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 1/12 (8.3%) 0/15 (0%) 0/72 (0%) 1/68 (1.5%) 0/51 (0%) 0/3 (0%) 1/11 (9.1%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Hypotension 0/30 (0%) 0/20 (0%) 0/51 (0%) 1/54 (1.9%) 1/50 (2%) 2/52 (3.8%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 2/50 (4%) 2/52 (3.8%) 1/49 (2%) 1/53 (1.9%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 1/15 (6.7%) 0/72 (0%) 0/68 (0%) 2/51 (3.9%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Orthostatic hypotension 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Peripheral venous disease 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/30 (0%) 0/20 (0%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 1/51 (2%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 1/12 (8.3%) 0/56 (0%) 0/8 (0%)
    Phlebitis 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)
    Phlebitis superficial 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/54 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 0/53 (0%) 0/51 (0%) 0/30 (0%) 1/20 (5%) 0/51 (0%) 0/50 (0%) 1/52 (1.9%) 0/49 (0%) 1/53 (1.9%) 0/51 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/19 (0%) 0/90 (0%) 0/89 (0%) 0/12 (0%) 0/15 (0%) 0/72 (0%) 0/68 (0%) 0/51 (0%) 0/3 (0%) 0/11 (0%) 0/12 (0%) 0/56 (0%) 0/8 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

    Results Point of Contact

    Name/Title Study Director
    Organization Amgen Inc.
    Phone 866-572-6436
    Email
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT00896532
    Other Study ID Numbers:
    • 20060326
    • 2008-005991-28
    First Posted:
    May 11, 2009
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020