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SALSA: Secondary Adjuvant Long Term Study With Arimidex

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00295620
Collaborator
(none)
3,484
Enrollment
62
Locations
2
Arms
160
Actual Duration (Months)
56.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

ABCSG 16 S.A.L.S.A is assessing the effect of further 2 years vs further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy. S.A.L.S.A. is a randomized open multicentered phase III study comparing the efficacy of secondary adjuvant endokrine treatment of Arimidex® (Anastrozol) for 2 or 5 years after primary adjuvant endokrine therapy in patients with hormonreceptor positive mammakarzinom. Patients are examined at screening, after 6 months, then every year until 5 years. The subsequent yearly follow up with mammographie and clinical examination ends 10 years after the screening. S.A.L.S.A. started in February 2004 and has recruited 3484 patients until June 2010 at 78 sites all over Austria.

Primary Endpoint:
  1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival
Secondary endpoint:

  1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival

  2. Comparison of fracture rate in both therapy groups

  3. Comparison of incidence of

  4. a secondary carcinoma except the contralateral mammacarcinoma

  5. contralateral mammacarcinoma in both therapie groups

Study Design

Study Type:
Interventional
Actual Enrollment :
3484 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy
Actual Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Anastrozol

1 mg per day for 2 years

Drug: Anastrozole
1mg tablet daily
Other Names:
  • Arimidex

    		•
    Experimental: Arm B: Anastrozol

    1 mg per day for 5 years

    Drug: Anastrozole
    1mg tablet daily
    Other Names:
  • Arimidex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free Survival After Prolonged Endocrine Treatment [DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years]

      To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.

    Secondary Outcome Measures

    1. Overall Survival After Prolonged Endocrine Treatment [Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years]

      To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.

    2. Time to First Clinical Fracture [Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.]

      To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).

    3. Time to Secondary Carcinoma [Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years]

      To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.

    4. Time to Contralateral Breast Cancer [Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years]

      To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie.

    2. No distant metastasis at randomization

    3. No relapse at randomization

    4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0

    5. Estrogen- and or progesterone positive before the beginningof primary endocrine therapy

    6. Endocrine therapy for 5 years (maximum deviation ±12 months)

    7. Therapy break (from the preliminary therapie) maximum 12 months.

    8. Informed Consent before the randomisation

    Exclusion criteria:

    1. Premenopausal patients or patients with non definable menopausal statusat time of randomisation

    2. Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)

    3. General contraindication respectively hypersensitivity to Anastrozol.

    4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.

    5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy

    6. Known liver- and/or kidneyinsufficiency

    7. Performance Index >2 according to WHO

    8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma

    9. Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.

    10. Lacking compliance of the patient

    11. Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial

    12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Amstetten Austria 3300
    2 Research Site Bad Ischl Austria 4820
    3 Research Site Baden Austria 2500
    4 Research Site Bregenz Austria 6900
    5 Research Site Dornbirn Austria 6853
    6 Research Site Eisenstadt Austria 7000
    7 Research Site Feldbach Austria 8330
    8 Research Site Feldkirch Austria 6807
    9 Research Site Freistadt Austria 4240
    10 Research Site Fuerstenfeld Austria 8280
    11 Research Site Gmunden Austria 4810
    12 Research Site Graz Austria 8036
    13 Research Site Guessing Austria 7540
    14 Research Site Hainburg Austria 2410
    15 Research Site Hall in Tirol Austria 6060
    16 Research Site Innsbruck Austria 6020
    17 Research Site Kirchdorf Austria 4560
    18 Research Site Klagenfurt Austria 8020
    19 Research Site Klagenfurt Austria 9020
    20 Research Site Klagenfurt Austria 9026
    21 Research Site Krems Austria 3500
    22 Research Site Kufstein Austria 6330
    23 Research Site Leoben Austria 8700
    24 Research Site Lienz Austria 9900
    25 Research Site Linz Austria 4010
    26 Research Site Linz Austria 4021
    27 Research Site Mistelbach Austria 2130
    28 Research Site Moedling Austria 2340
    29 Research Site Neunkirchen Austria 2620
    30 Research Site Oberpullendorf Austria 7350
    31 Research Site Oberwart Austria 7400
    32 Research Site Ried im Innkreis Austria 4910
    33 Research Site Rottenmann Austria 8786
    34 Research Site Salzburg Austria 5020
    35 Research Site Scheibbs Austria 3270
    36 Research Site Schladming Austria 8970
    37 Research Site Schwarzach Austria 5620
    38 Research Site St. Poelten Austria 3100
    39 Research Site St. Veit an der Glan Austria 9300
    40 Research Site Steyr Austria 4400
    41 Research Site Vienna Austria 1050
    42 Research Site Vienna Austria 1070
    43 Research Site Vienna Austria 1090
    44 Research Site Vienna Austria 1130
    45 Research Site Vienna Austria 1210
    46 Research Site Vienna Austria A-1090
    47 Research Site Villach Austria 9500
    48 Research Site Villach Austria 9504
    49 Research Site Voecklabruck Austria 4840
    50 Research Site Waidhofen an der Thaya Austria 3830
    51 Research Site Weiz Austria 8160
    52 Research Site Wels Austria 4600
    53 Research Site Wiener Neustadt Austria 2700
    54 Research Site Wien Austria 1021
    55 Research Site Wien Austria 1090
    56 Research Site Wien Austria 1130
    57 Research Site Wien Austria 1140
    58 Research Site Wien Austria 1160
    59 Research Site Wien Austria 1180
    60 Research Site Wien Austria 1220
    61 Research Site Wolfsberg Austria 9400
    62 Research Site Zams Austria 6511

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: AstraZeneca Austria Medical Director, MD, AstraZeneca

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00295620
    Other Study ID Numbers:
    • 1033AU/0003
    • ABCSG 16
    • D5392L00016
    • SALSA
    First Posted:
    Feb 24, 2006
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by AstraZeneca
    Hormone receptor positive breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Anastrozole

    Study Results

    Participant Flow

    Recruitment Details The first patient was randomized Feb 26, 2004, the last patient was randomized June 30, 2010. Randomization took place in 75 Austrian clinical sites. In total, 3,484 patients were enrolled.
    Pre-assignment Detail Fourteen patients did not sign the Informed Consent, resulting in 3,470 patients who started the trial.
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Period Title: Overall Study
    STARTED 1732 1738
    Safety Analysis Set 1705 1710
    COMPLETED 860 842
    NOT COMPLETED 872 896

    Baseline Characteristics

    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol Total
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years Total of all reporting groups
    Overall Participants 1732 1738 3470
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    65
    64
    64
    Sex: Female, Male (Count of Participants)
    Female
    1732
    100%
    1738
    100%
    3470
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    pN-stage (Count of Participants)
    pN0
    1140
    65.8%
    1162
    66.9%
    2302
    66.3%
    pN1
    551
    31.8%
    523
    30.1%
    1074
    31%
    pN2
    30
    1.7%
    41
    2.4%
    71
    2%
    pN3
    7
    0.4%
    8
    0.5%
    15
    0.4%
    Unknown
    4
    0.2%
    4
    0.2%
    8
    0.2%
    pT-stage (Count of Participants)
    pT1
    1254
    72.4%
    1254
    72.2%
    2508
    72.3%
    pT2
    440
    25.4%
    442
    25.4%
    882
    25.4%
    pT3
    30
    1.7%
    32
    1.8%
    62
    1.8%
    pTx
    4
    0.2%
    6
    0.3%
    10
    0.3%
    Unknown
    4
    0.2%
    4
    0.2%
    8
    0.2%
    Previous Chemotherapy (Count of Participants)
    Chemotherapy containing anthracycline
    246
    14.2%
    236
    13.6%
    482
    13.9%
    Chemotherapy containing taxane
    93
    5.4%
    95
    5.5%
    188
    5.4%
    Other chemotherapy
    167
    9.6%
    163
    9.4%
    330
    9.5%
    No chemotherapy
    1224
    70.7%
    1241
    71.4%
    2465
    71%
    Unknown
    2
    0.1%
    3
    0.2%
    5
    0.1%
    Previous Endocrine Therapy (Count of Participants)
    2 years of anti-estrogen + 3 years Anastrozole
    416
    24%
    419
    24.1%
    835
    24.1%
    5 years of anti-estrogen
    855
    49.4%
    862
    49.6%
    1717
    49.5%
    Another, comparable endocrine therapy
    459
    26.5%
    454
    26.1%
    913
    26.3%
    Unknown
    2
    0.1%
    3
    0.2%
    5
    0.1%
    Estrogen Receptor Status (Count of Participants)
    Negative
    45
    2.6%
    46
    2.6%
    91
    2.6%
    Positive (+/++/+++)
    1686
    97.3%
    1689
    97.2%
    3375
    97.3%
    Unknown
    1
    0.1%
    3
    0.2%
    4
    0.1%
    Progesterone Receptor Status (Count of Participants)
    Negative
    332
    19.2%
    356
    20.5%
    688
    19.8%
    Positive (+/++/+++)
    1398
    80.7%
    1375
    79.1%
    2773
    79.9%
    Unknown
    2
    0.1%
    7
    0.4%
    9
    0.3%
    Surgery Type (Count of Participants)
    Breast-conserving surgery
    1360
    78.5%
    1405
    80.8%
    2765
    79.7%
    Modified radical mastectomy
    367
    21.2%
    319
    18.4%
    686
    19.8%
    Other
    4
    0.2%
    12
    0.7%
    16
    0.5%
    Unknown
    1
    0.1%
    2
    0.1%
    3
    0.1%
    Sentinel Node Biopsy (Count of Participants)
    No
    900
    52%
    887
    51%
    1787
    51.5%
    Yes
    820
    47.3%
    836
    48.1%
    1656
    47.7%
    Unknown
    12
    0.7%
    15
    0.9%
    27
    0.8%
    Axillary Surgery (Count of Participants)
    No
    386
    22.3%
    405
    23.3%
    791
    22.8%
    Yes
    1345
    77.7%
    1331
    76.6%
    2676
    77.1%
    Unknown
    1
    0.1%
    2
    0.1%
    3
    0.1%
    Tumor Grading (Count of Participants)
    G1
    247
    14.3%
    261
    15%
    508
    14.6%
    G2
    1107
    63.9%
    1090
    62.7%
    2197
    63.3%
    G3
    326
    18.8%
    348
    20%
    674
    19.4%
    GX
    27
    1.6%
    12
    0.7%
    39
    1.1%
    Unknown
    25
    1.4%
    27
    1.6%
    52
    1.5%
    Previous Radiotherapy (Count of Participants)
    No
    356
    20.6%
    327
    18.8%
    683
    19.7%
    Yes
    1373
    79.3%
    1407
    81%
    2780
    80.1%
    Unknown
    3
    0.2%
    4
    0.2%
    7
    0.2%

    Outcome Measures

    1. Primary Outcome
    Title Disease-free Survival After Prolonged Endocrine Treatment
    Description To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.
    Time Frame DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years

    Outcome Measure Data

    Analysis Population Description
    Per-Protocol (PP) Population, defined as all randomized patients who signed the informed consent who complied with the inclusion and exclusion criteria, who had at least one follow-up examination after randomization and who survived without recurrence for two years.
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Measure Participants 1281 1323
    Median (Inter-Quartile Range) [Years]
    NA
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: Anastrozol, Arm B: Anastrozol
    Comments Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.425
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.93
    Confidence Interval (2-Sided) 95%
    0.79 to 1.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival After Prolonged Endocrine Treatment
    Description To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.
    Time Frame Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years

    Outcome Measure Data

    Analysis Population Description
    All randomized patients who signed the informed consent and who did not die during two first two years
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Measure Participants 1665 1670
    Median (Inter-Quartile Range) [Years]
    NA
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: Anastrozol, Arm B: Anastrozol
    Comments Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.867
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.83 to 1.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Time to First Clinical Fracture
    Description To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).
    Time Frame Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.

    Outcome Measure Data

    Analysis Population Description
    All randomized patients who signed the informed consent and who had no fractures during the first two years
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Measure Participants 1555 1570
    Median (Inter-Quartile Range) [Years]
    NA
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: Anastrozol, Arm B: Anastrozol
    Comments Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.052
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.35
    Confidence Interval (2-Sided) 95%
    1.00 to 1.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Time to Secondary Carcinoma
    Description To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.
    Time Frame Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years

    Outcome Measure Data

    Analysis Population Description
    All randomized patients who signed the informed consent and had no secondary carcinoma (excluding contralateral mammacarcinoma) during the first two years
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Measure Participants 1620 1620
    Median (Inter-Quartile Range) [Years]
    NA
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: Anastrozol, Arm B: Anastrozol
    Comments Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.678
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.81 to 1.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Time to Contralateral Breast Cancer
    Description To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.
    Time Frame Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years

    Outcome Measure Data

    Analysis Population Description
    All randomized patients who signed the informed consent and had no contralateral mammacarcinoma during the first two years
    Arm/Group Title Arm A: Anastrozol Arm B: Anastrozol
    Arm/Group Description 1 mg per day for 2 years 1 mg per day for 5 years
    Measure Participants 1636 1641
    Median (Inter-Quartile Range) [Years]
    NA
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: Anastrozol, Arm B: Anastrozol
    Comments Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.531
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.75 to 1.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment
    Adverse Event Reporting Description All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
    Arm/Group Title Arm B: Anastrozol - 1 mg Per Day for 5 Years Arm A: Anastrozol - 1 mg Per Day for 2 Years
    Arm/Group Description Description (Arm-group) Description (Arm-group)
    All Cause Mortality
    Arm B: Anastrozol - 1 mg Per Day for 5 Years Arm A: Anastrozol - 1 mg Per Day for 2 Years
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 207/1738 (11.9%) 207/1732 (12%)
    Serious Adverse Events
    Arm B: Anastrozol - 1 mg Per Day for 5 Years Arm A: Anastrozol - 1 mg Per Day for 2 Years
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 687/1710 (40.2%) 452/1705 (26.5%)
    Blood and lymphatic system disorders
    Anaemia 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Anaemia macrocytic 0/1710 (0%) 0 1/1705 (0.1%) 2
    Bone marrow oedema 3/1710 (0.2%) 3 0/1705 (0%) 0
    Haemolytic anaemia 1/1710 (0.1%) 1 0/1705 (0%) 0
    Immune thrombocytopenic purpura 1/1710 (0.1%) 2 0/1705 (0%) 0
    Leukopenia 0/1710 (0%) 0 1/1705 (0.1%) 2
    Lymph node calcification 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lymphadenitis 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lymphadenopathy 3/1710 (0.2%) 6 0/1705 (0%) 0
    Mastocytosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Spontaneous haematoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Angina pectoris 4/1710 (0.2%) 6 4/1705 (0.2%) 9
    Aortic valve disease 0/1710 (0%) 0 1/1705 (0.1%) 2
    Aortic valve prolapse 1/1710 (0.1%) 2 0/1705 (0%) 0
    Aortic valve stenosis 2/1710 (0.1%) 3 0/1705 (0%) 0
    Arrhythmia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Arteriosclerosis coronary artery 0/1710 (0%) 0 1/1705 (0.1%) 2
    Atrial fibrillation 17/1710 (1%) 37 6/1705 (0.4%) 10
    Atrial flutter 1/1710 (0.1%) 2 0/1705 (0%) 0
    Atrial tachycardia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Atrioventricular block 1/1710 (0.1%) 2 0/1705 (0%) 0
    Atrioventricular block complete 2/1710 (0.1%) 4 0/1705 (0%) 0
    Bradycardia 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Cardiac arrest 1/1710 (0.1%) 3 0/1705 (0%) 0
    Cardiac disorder 0/1710 (0%) 0 1/1705 (0.1%) 3
    Cardiac failure 7/1710 (0.4%) 15 6/1705 (0.4%) 12
    Cardiac flutter 1/1710 (0.1%) 2 0/1705 (0%) 0
    Cardiomyopathy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Cardiopulmonary failure 1/1710 (0.1%) 2 0/1705 (0%) 0
    Congestive cardiomyopathy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Cor pulmonale chronic 1/1710 (0.1%) 4 0/1705 (0%) 0
    Coronary artery disease 8/1710 (0.5%) 17 6/1705 (0.4%) 13
    Intracardiac thrombus 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ischaemic cardiomyopathy 2/1710 (0.1%) 4 0/1705 (0%) 0
    Mitral valve disease 0/1710 (0%) 0 1/1705 (0.1%) 2
    Mitral valve disease mixed 1/1710 (0.1%) 1 0/1705 (0%) 0
    Mitral valve incompetence 4/1710 (0.2%) 7 0/1705 (0%) 0
    Myocardial infarction 4/1710 (0.2%) 8 2/1705 (0.1%) 3
    Myocardial ischaemia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Palpitations 1/1710 (0.1%) 1 0/1705 (0%) 0
    Pulmonary valve incompetence 1/1710 (0.1%) 1 0/1705 (0%) 0
    Right ventricular failure 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Sinus node dysfunction 1/1710 (0.1%) 2 0/1705 (0%) 0
    Sinus tachycardia 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Supraventricular tachycardia 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Tachycardia 1/1710 (0.1%) 1 3/1705 (0.2%) 9
    Tachycardia paroxysmal 0/1710 (0%) 0 1/1705 (0.1%) 2
    Tricuspid valve incompetence 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ventricular extrasystoles 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Ventricular tachycardia 0/1710 (0%) 0 2/1705 (0.1%) 3
    Wolff-parkinson-white syndrome 0/1710 (0%) 0 1/1705 (0.1%) 1
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli 0/1710 (0%) 0 1/1705 (0.1%) 2
    Anomalous arrangement of pancreaticobiliary duct 1/1710 (0.1%) 2 0/1705 (0%) 0
    Choledochal cyst 0/1710 (0%) 0 1/1705 (0.1%) 2
    Congenital uterine anomaly 1/1710 (0.1%) 2 0/1705 (0%) 0
    Corneal opacity congenital 1/1710 (0.1%) 2 0/1705 (0%) 0
    Developmental hip dysplasia 1/1710 (0.1%) 1 0/1705 (0%) 0
    Epidermal naevus 0/1710 (0%) 0 1/1705 (0.1%) 2
    Foramen magnum stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ear and labyrinth disorders
    Cupulolithiasis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Deafness 1/1710 (0.1%) 2 0/1705 (0%) 0
    Deafness unilateral 0/1710 (0%) 0 2/1705 (0.1%) 4
    Inner ear disorder 1/1710 (0.1%) 1 0/1705 (0%) 0
    Meniere's disease 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Tinnitus 2/1710 (0.1%) 3 2/1705 (0.1%) 4
    Tympanosclerosis 0/1710 (0%) 0 1/1705 (0.1%) 1
    Vertigo 8/1710 (0.5%) 15 5/1705 (0.3%) 9
    Vertigo positional 2/1710 (0.1%) 3 2/1705 (0.1%) 4
    Endocrine disorders
    Goitre 12/1710 (0.7%) 22 4/1705 (0.2%) 8
    Hyperparathyroidism 0/1710 (0%) 0 1/1705 (0.1%) 2
    Hyperparathyroidism primary 2/1710 (0.1%) 3 0/1705 (0%) 0
    Hyperthyroidism 3/1710 (0.2%) 6 1/1705 (0.1%) 2
    Thyroid haemorrhage 1/1710 (0.1%) 1 0/1705 (0%) 0
    Thyroid mass 0/1710 (0%) 0 2/1705 (0.1%) 3
    Eye disorders
    Age-related macular degeneration 1/1710 (0.1%) 2 0/1705 (0%) 0
    Astigmatism 1/1710 (0.1%) 3 0/1705 (0%) 0
    Blepharochalasis 2/1710 (0.1%) 4 0/1705 (0%) 0
    Cataract 26/1710 (1.5%) 68 12/1705 (0.7%) 26
    Cataract cortical 4/1710 (0.2%) 10 0/1705 (0%) 0
    Cataract nuclear 2/1710 (0.1%) 5 0/1705 (0%) 0
    Dacryostenosis acquired 0/1710 (0%) 0 1/1705 (0.1%) 2
    Exfoliation syndrome 0/1710 (0%) 0 1/1705 (0.1%) 2
    Eye haemorrhage 1/1710 (0.1%) 1 0/1705 (0%) 0
    Glaucoma 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Lens dislocation 1/1710 (0.1%) 1 0/1705 (0%) 0
    Macular degeneration 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Macular hole 3/1710 (0.2%) 6 0/1705 (0%) 0
    Maculopathy 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Myopia 1/1710 (0.1%) 3 0/1705 (0%) 0
    Photopsia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Retinal artery occlusion 0/1710 (0%) 0 1/1705 (0.1%) 3
    Retinal degeneration 1/1710 (0.1%) 2 0/1705 (0%) 0
    Retinal detachment 2/1710 (0.1%) 4 0/1705 (0%) 0
    Retinal disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Retinal haemorrhage 0/1710 (0%) 0 1/1705 (0.1%) 2
    Retinal tear 1/1710 (0.1%) 2 0/1705 (0%) 0
    Retinopathy hypertensive 1/1710 (0.1%) 2 0/1705 (0%) 0
    Vitreous haemorrhage 1/1710 (0.1%) 1 0/1705 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Abdominal hernia 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Abdominal pain 13/1710 (0.8%) 22 4/1705 (0.2%) 12
    Abdominal pain lower 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Abdominal pain upper 3/1710 (0.2%) 7 2/1705 (0.1%) 5
    Abdominal symptom 1/1710 (0.1%) 2 0/1705 (0%) 0
    Abdominal wall disorder 0/1710 (0%) 0 1/1705 (0.1%) 2
    Abnormal faeces 1/1710 (0.1%) 2 0/1705 (0%) 0
    Acute abdomen 1/1710 (0.1%) 2 0/1705 (0%) 0
    Anal haemorrhage 1/1710 (0.1%) 2 0/1705 (0%) 0
    Anal incontinence 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Anal polyp 1/1710 (0.1%) 2 0/1705 (0%) 0
    Anorectal discomfort 1/1710 (0.1%) 2 0/1705 (0%) 0
    Anorectal disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ascites 1/1710 (0.1%) 2 0/1705 (0%) 0
    Chronic gastritis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Coeliac disease 1/1710 (0.1%) 2 0/1705 (0%) 0
    Colitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Colitis ischaemic 0/1710 (0%) 0 1/1705 (0.1%) 2
    Colitis microscopic 1/1710 (0.1%) 1 0/1705 (0%) 0
    Colitis ulcerative 2/1710 (0.1%) 3 0/1705 (0%) 0
    Constipation 4/1710 (0.2%) 7 2/1705 (0.1%) 2
    Dental alveolar anomaly 0/1710 (0%) 0 1/1705 (0.1%) 2
    Diarrhoea 12/1710 (0.7%) 21 6/1705 (0.4%) 11
    Diarrhoea haemorrhagic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Diverticular perforation 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Diverticulum 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Diverticulum intestinal 6/1710 (0.4%) 12 2/1705 (0.1%) 3
    Duodenal ulcer haemorrhage 1/1710 (0.1%) 2 0/1705 (0%) 0
    Duodenitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Dyspepsia 2/1710 (0.1%) 3 0/1705 (0%) 0
    Dysphagia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Enteritis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Enterocele 0/1710 (0%) 0 2/1705 (0.1%) 4
    Erosive duodenitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Gastric polyps 1/1710 (0.1%) 2 0/1705 (0%) 0
    Gastric ulcer 1/1710 (0.1%) 1 1/1705 (0.1%) 4
    Gastric ulcer haemorrhage 1/1710 (0.1%) 1 0/1705 (0%) 0
    Gastritis 3/1710 (0.2%) 5 5/1705 (0.3%) 10
    Gastritis erosive 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Gastrointestinal disorder 2/1710 (0.1%) 4 0/1705 (0%) 0
    Gastrointestinal haemorrhage 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Gastrooesophageal reflux disease 5/1710 (0.3%) 10 3/1705 (0.2%) 6
    Haematochezia 2/1710 (0.1%) 3 4/1705 (0.2%) 7
    Haemorrhoids 5/1710 (0.3%) 10 0/1705 (0%) 0
    Hiatus hernia 3/1710 (0.2%) 5 2/1705 (0.1%) 4
    Ileus 2/1710 (0.1%) 4 1/1705 (0.1%) 1
    Inflammatory bowel disease 1/1710 (0.1%) 1 0/1705 (0%) 0
    Inguinal hernia 2/1710 (0.1%) 4 2/1705 (0.1%) 4
    Intestinal fistula 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intestinal polyp 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intestinal prolapse 1/1710 (0.1%) 2 0/1705 (0%) 0
    Large intestine perforation 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Large intestine polyp 16/1710 (0.9%) 28 8/1705 (0.5%) 17
    Mallory-weiss syndrome 1/1710 (0.1%) 2 0/1705 (0%) 0
    Mechanical ileus 0/1710 (0%) 0 1/1705 (0.1%) 2
    Mouth haemorrhage 1/1710 (0.1%) 2 0/1705 (0%) 0
    Nausea 7/1710 (0.4%) 13 4/1705 (0.2%) 14
    Oesophagitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Pancreatic cyst 1/1710 (0.1%) 1 0/1705 (0%) 0
    Pancreatitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Pancreatitis acute 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Pancreatitis necrotising 0/1710 (0%) 0 1/1705 (0.1%) 2
    Proctitis 2/1710 (0.1%) 6 0/1705 (0%) 0
    Rectal polyp 5/1710 (0.3%) 10 1/1705 (0.1%) 2
    Subileus 1/1710 (0.1%) 2 0/1705 (0%) 0
    Tooth disorder 0/1710 (0%) 0 1/1705 (0.1%) 4
    Umbilical hernia 1/1710 (0.1%) 2 2/1705 (0.1%) 3
    Vomiting 4/1710 (0.2%) 8 3/1705 (0.2%) 10
    General disorders
    Asthenia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Calcinosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Chest discomfort 0/1710 (0%) 0 2/1705 (0.1%) 3
    Chest pain 9/1710 (0.5%) 19 4/1705 (0.2%) 6
    Condition aggravated 1/1710 (0.1%) 1 0/1705 (0%) 0
    Death 6/1710 (0.4%) 12 0/1705 (0%) 0
    Fat necrosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Fatigue 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Fibrosis 0/1710 (0%) 0 1/1705 (0.1%) 2
    General physical health deterioration 1/1710 (0.1%) 4 4/1705 (0.2%) 7
    Hernia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hyperplasia 0/1710 (0%) 0 2/1705 (0.1%) 4
    Ill-defined disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Impaired healing 4/1710 (0.2%) 8 1/1705 (0.1%) 2
    Implant site extravasation 0/1710 (0%) 0 1/1705 (0.1%) 1
    Implant site fibrosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Incarcerated hernia 0/1710 (0%) 0 1/1705 (0.1%) 2
    Inflammation 0/1710 (0%) 0 1/1705 (0.1%) 2
    Multiple organ dysfunction syndrome 1/1710 (0.1%) 2 0/1705 (0%) 0
    Oedema mucosal 0/1710 (0%) 0 1/1705 (0.1%) 1
    Pain 1/1710 (0.1%) 2 0/1705 (0%) 0
    Peripheral swelling 1/1710 (0.1%) 2 0/1705 (0%) 0
    Polyp 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Pyrexia 4/1710 (0.2%) 8 2/1705 (0.1%) 4
    Sudden cardiac death 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hepatobiliary disorders
    Ampulla of vater stenosis 1/1710 (0.1%) 1 0/1705 (0%) 0
    Bile duct stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Bile duct stone 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Biliary tract disorder 0/1710 (0%) 0 1/1705 (0.1%) 1
    Cholecystitis 3/1710 (0.2%) 6 2/1705 (0.1%) 4
    Cholecystitis acute 1/1710 (0.1%) 2 2/1705 (0.1%) 3
    Cholecystitis chronic 4/1710 (0.2%) 5 1/1705 (0.1%) 2
    Cholelithiasis 14/1710 (0.8%) 27 15/1705 (0.9%) 27
    Gallbladder disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hepatic cyst 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hepatic steatosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Hepatitis cholestatic 0/1710 (0%) 0 1/1705 (0.1%) 2
    Jaundice 1/1710 (0.1%) 4 0/1705 (0%) 0
    Non-alcoholic steatohepatitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Immune system disorders
    Allergy to arthropod bite 1/1710 (0.1%) 1 0/1705 (0%) 0
    Infections and infestations
    Abdominal abscess 0/1710 (0%) 0 1/1705 (0.1%) 2
    Abdominal wall abscess 0/1710 (0%) 0 1/1705 (0.1%) 2
    Abscess of salivary gland 1/1710 (0.1%) 1 0/1705 (0%) 0
    Acute sinusitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Appendicitis 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Bronchitis 3/1710 (0.2%) 5 3/1705 (0.2%) 4
    Campylobacter gastroenteritis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Chest wall abscess 1/1710 (0.1%) 2 0/1705 (0%) 0
    Conjunctivitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Diverticulitis 5/1710 (0.3%) 13 7/1705 (0.4%) 16
    Diverticulitis intestinal haemorrhagic 0/1710 (0%) 0 1/1705 (0.1%) 2
    Ear infection 1/1710 (0.1%) 2 0/1705 (0%) 0
    Encephalitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Erysipelas 6/1710 (0.4%) 13 7/1705 (0.4%) 10
    Extradural abscess 1/1710 (0.1%) 2 0/1705 (0%) 0
    Fungal infection 1/1710 (0.1%) 2 0/1705 (0%) 0
    Gastroenteritis 4/1710 (0.2%) 7 3/1705 (0.2%) 6
    Helicobacter gastritis 3/1710 (0.2%) 3 1/1705 (0.1%) 2
    Herpes zoster 1/1710 (0.1%) 2 0/1705 (0%) 0
    Infected dermal cyst 1/1710 (0.1%) 2 0/1705 (0%) 0
    Intervertebral discitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Meningitis viral 1/1710 (0.1%) 2 0/1705 (0%) 0
    Nasopharyngitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Neuroborreliosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Osteomyelitis acute 1/1710 (0.1%) 2 0/1705 (0%) 0
    Peritonitis 0/1710 (0%) 0 2/1705 (0.1%) 3
    Pharyngitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Pneumonia 11/1710 (0.6%) 22 5/1705 (0.3%) 12
    Pyelonephritis 1/1710 (0.1%) 1 2/1705 (0.1%) 4
    Pyometra 0/1710 (0%) 0 1/1705 (0.1%) 2
    Respiratory tract infection 0/1710 (0%) 0 2/1705 (0.1%) 5
    Rhinitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Salpingitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Sepsis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Sinobronchitis 0/1710 (0%) 0 1/1705 (0.1%) 1
    Sinusitis 0/1710 (0%) 0 2/1705 (0.1%) 4
    Skin infection 1/1710 (0.1%) 2 0/1705 (0%) 0
    Subcutaneous abscess 1/1710 (0.1%) 1 0/1705 (0%) 0
    Tonsillitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Urethral carbuncle 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Urinary tract infection 11/1710 (0.6%) 23 0/1705 (0%) 0
    Urosepsis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Vaginal infection 0/1710 (0%) 0 1/1705 (0.1%) 2
    Vestibular neuronitis 2/1710 (0.1%) 2 0/1705 (0%) 0
    Vulval abscess 0/1710 (0%) 0 1/1705 (0.1%) 2
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/1710 (0.1%) 1 0/1705 (0%) 0
    Anaemia postoperative 0/1710 (0%) 0 1/1705 (0.1%) 2
    Ankle fracture 20/1710 (1.2%) 38 5/1705 (0.3%) 9
    Bankart lesion 0/1710 (0%) 0 1/1705 (0.1%) 1
    Bone contusion 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Clavicle fracture 1/1710 (0.1%) 1 0/1705 (0%) 0
    Compression fracture 0/1710 (0%) 0 2/1705 (0.1%) 4
    Concussion 2/1710 (0.1%) 4 3/1705 (0.2%) 6
    Contusion 10/1710 (0.6%) 18 4/1705 (0.2%) 10
    Coronary bypass thrombosis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Craniocerebral injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Facial bones fracture 2/1710 (0.1%) 4 1/1705 (0.1%) 1
    Fall 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Femoral neck fracture 5/1710 (0.3%) 9 2/1705 (0.1%) 4
    Femur fracture 8/1710 (0.5%) 12 3/1705 (0.2%) 6
    Fibula fracture 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Foot fracture 4/1710 (0.2%) 8 7/1705 (0.4%) 14
    Forearm fracture 2/1710 (0.1%) 4 3/1705 (0.2%) 5
    Fracture 3/1710 (0.2%) 5 3/1705 (0.2%) 4
    Fractured sacrum 2/1710 (0.1%) 4 0/1705 (0%) 0
    Hand fracture 6/1710 (0.4%) 12 2/1705 (0.1%) 4
    Head injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Hip fracture 3/1710 (0.2%) 5 0/1705 (0%) 0
    Humerus fracture 13/1710 (0.8%) 24 5/1705 (0.3%) 8
    Ilium fracture 1/1710 (0.1%) 2 0/1705 (0%) 0
    Incisional hernia 6/1710 (0.4%) 10 2/1705 (0.1%) 4
    Incisional hernia, obstructive 1/1710 (0.1%) 2 0/1705 (0%) 0
    Injury 0/1710 (0%) 0 1/1705 (0.1%) 1
    Intentional overdose 1/1710 (0.1%) 2 0/1705 (0%) 0
    Intestinal anastomosis complication 0/1710 (0%) 0 1/1705 (0.1%) 1
    Joint dislocation 2/1710 (0.1%) 6 1/1705 (0.1%) 1
    Keratorhexis 1/1710 (0.1%) 1 0/1705 (0%) 0
    Laceration 2/1710 (0.1%) 4 0/1705 (0%) 0
    Ligament injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Ligament rupture 0/1710 (0%) 0 1/1705 (0.1%) 2
    Ligament sprain 1/1710 (0.1%) 2 0/1705 (0%) 0
    Limb injury 1/1710 (0.1%) 2 0/1705 (0%) 0
    Lower limb fracture 2/1710 (0.1%) 3 1/1705 (0.1%) 1
    Lumbar vertebral fracture 3/1710 (0.2%) 6 5/1705 (0.3%) 11
    Meniscus injury 14/1710 (0.8%) 27 4/1705 (0.2%) 8
    Multiple fractures 0/1710 (0%) 0 1/1705 (0.1%) 2
    Multiple injuries 0/1710 (0%) 0 1/1705 (0.1%) 2
    Muscle injury 1/1710 (0.1%) 1 0/1705 (0%) 0
    Neck injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Overdose 1/1710 (0.1%) 4 0/1705 (0%) 0
    Patella fracture 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Pelvic fracture 2/1710 (0.1%) 3 0/1705 (0%) 0
    Post procedural complication 0/1710 (0%) 0 1/1705 (0.1%) 2
    Postoperative wound complication 2/1710 (0.1%) 4 0/1705 (0%) 0
    Pubis fracture 4/1710 (0.2%) 7 1/1705 (0.1%) 4
    Radiation oesophagitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Radius fracture 29/1710 (1.7%) 55 21/1705 (1.2%) 40
    Rib fracture 3/1710 (0.2%) 4 4/1705 (0.2%) 6
    Road traffic accident 1/1710 (0.1%) 1 0/1705 (0%) 0
    Scapula fracture 1/1710 (0.1%) 2 0/1705 (0%) 0
    Skin abrasion 2/1710 (0.1%) 4 0/1705 (0%) 0
    Skin injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Spinal compression fracture 1/1710 (0.1%) 2 2/1705 (0.1%) 3
    Spinal fracture 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Splenic rupture 1/1710 (0.1%) 2 0/1705 (0%) 0
    Stress fracture 2/1710 (0.1%) 4 0/1705 (0%) 0
    Subarachnoid haemorrhage 3/1710 (0.2%) 6 0/1705 (0%) 0
    Subdural haemorrhage 0/1710 (0%) 0 1/1705 (0.1%) 4
    Suture related complication 0/1710 (0%) 0 2/1705 (0.1%) 4
    Tendon rupture 4/1710 (0.2%) 6 2/1705 (0.1%) 4
    Thoracic vertebral fracture 3/1710 (0.2%) 6 3/1705 (0.2%) 5
    Tibia fracture 5/1710 (0.3%) 8 3/1705 (0.2%) 4
    Toxicity to various agents 0/1710 (0%) 0 1/1705 (0.1%) 2
    Traumatic fracture 1/1710 (0.1%) 4 0/1705 (0%) 0
    Traumatic haematoma 2/1710 (0.1%) 2 1/1705 (0.1%) 2
    Traumatic lung injury 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ulna fracture 3/1710 (0.2%) 5 1/1705 (0.1%) 2
    Upper limb fracture 5/1710 (0.3%) 8 4/1705 (0.2%) 7
    Vascular pseudoaneurysm 0/1710 (0%) 0 1/1705 (0.1%) 1
    Wrist fracture 4/1710 (0.2%) 7 1/1705 (0.1%) 2
    Investigations
    Angiogram 1/1710 (0.1%) 2 0/1705 (0%) 0
    Biopsy lymph gland 1/1710 (0.1%) 2 0/1705 (0%) 0
    Blood creatinine increased 2/1710 (0.1%) 3 0/1705 (0%) 0
    Blood glucose abnormal 1/1710 (0.1%) 2 0/1705 (0%) 0
    Blood pressure increased 0/1710 (0%) 0 1/1705 (0.1%) 2
    Bronchoscopy 0/1710 (0%) 0 1/1705 (0.1%) 1
    Carcinoembryonic antigen increased 1/1710 (0.1%) 2 0/1705 (0%) 0
    Colonoscopy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Electrocardiogram change 0/1710 (0%) 0 1/1705 (0.1%) 2
    Endoscopic retrograde cholangiopancreatography 0/1710 (0%) 0 1/1705 (0.1%) 2
    Endoscopy upper gastrointestinal tract 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lipids abnormal 1/1710 (0.1%) 2 0/1705 (0%) 0
    Liver function test increased 1/1710 (0.1%) 2 0/1705 (0%) 0
    Occult blood positive 0/1710 (0%) 0 1/1705 (0.1%) 1
    Platelet count decreased 1/1710 (0.1%) 2 0/1705 (0%) 0
    Smear cervix abnormal 1/1710 (0.1%) 4 1/1705 (0.1%) 4
    Tumour marker increased 1/1710 (0.1%) 2 0/1705 (0%) 0
    Varicella virus test positive 1/1710 (0.1%) 2 0/1705 (0%) 0
    Weight decreased 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Metabolism and nutrition disorders
    Calciphylaxis 1/1710 (0.1%) 4 0/1705 (0%) 0
    Dehydration 2/1710 (0.1%) 3 1/1705 (0.1%) 2
    Diabetes mellitus 2/1710 (0.1%) 4 0/1705 (0%) 0
    Diabetes mellitus inadequate control 2/1710 (0.1%) 3 0/1705 (0%) 0
    Glucose tolerance impaired 0/1710 (0%) 0 1/1705 (0.1%) 1
    Hypercholesterolaemia 0/1710 (0%) 0 1/1705 (0.1%) 4
    Hyperglycaemia 3/1710 (0.2%) 6 0/1705 (0%) 0
    Hyperkalaemia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hyperlipidaemia 0/1710 (0%) 0 1/1705 (0.1%) 1
    Hypokalaemia 1/1710 (0.1%) 1 1/1705 (0.1%) 1
    Hyponatraemia 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Obesity 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Type 2 diabetes mellitus 1/1710 (0.1%) 2 0/1705 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 7/1710 (0.4%) 10 2/1705 (0.1%) 4
    Arthritis 2/1710 (0.1%) 3 0/1705 (0%) 0
    Arthrofibrosis 1/1710 (0.1%) 1 0/1705 (0%) 0
    Arthropathy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Back pain 7/1710 (0.4%) 13 3/1705 (0.2%) 3
    Bone pain 1/1710 (0.1%) 2 0/1705 (0%) 0
    Bursitis 1/1710 (0.1%) 2 3/1705 (0.2%) 6
    Chondropathy 1/1710 (0.1%) 3 0/1705 (0%) 0
    Exostosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Foot deformity 14/1710 (0.8%) 28 14/1705 (0.8%) 30
    Intervertebral disc disorder 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intervertebral disc protrusion 15/1710 (0.9%) 29 9/1705 (0.5%) 15
    Joint range of motion decreased 3/1710 (0.2%) 4 1/1705 (0.1%) 4
    Joint stiffness 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lumbar spinal stenosis 3/1710 (0.2%) 6 3/1705 (0.2%) 4
    Muscular weakness 1/1710 (0.1%) 1 0/1705 (0%) 0
    Musculoskeletal disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Musculoskeletal pain 1/1710 (0.1%) 2 2/1705 (0.1%) 3
    Musculoskeletal stiffness 1/1710 (0.1%) 2 0/1705 (0%) 0
    Myopathy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Myosclerosis 2/1710 (0.1%) 4 0/1705 (0%) 0
    Neck pain 1/1710 (0.1%) 2 0/1705 (0%) 0
    Osteoarthritis 74/1710 (4.3%) 164 29/1705 (1.7%) 60
    Osteochondrosis 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Osteonecrosis 2/1710 (0.1%) 4 0/1705 (0%) 0
    Osteoporosis 4/1710 (0.2%) 8 3/1705 (0.2%) 8
    Osteoporotic fracture 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Pain in extremity 4/1710 (0.2%) 7 3/1705 (0.2%) 7
    Plica syndrome 0/1710 (0%) 0 1/1705 (0.1%) 2
    Polyarthritis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Rheumatic disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Rheumatoid arthritis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Rotator cuff syndrome 1/1710 (0.1%) 2 5/1705 (0.3%) 9
    Spinal column stenosis 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Spinal deformity 0/1710 (0%) 0 1/1705 (0.1%) 2
    Spinal fusion acquired 1/1710 (0.1%) 2 0/1705 (0%) 0
    Spinal osteoarthritis 3/1710 (0.2%) 5 0/1705 (0%) 0
    Spinal pain 0/1710 (0%) 0 2/1705 (0.1%) 6
    Spondylolisthesis 5/1710 (0.3%) 10 2/1705 (0.1%) 2
    Synovitis 3/1710 (0.2%) 6 1/1705 (0.1%) 2
    Tendon pain 0/1710 (0%) 0 1/1705 (0.1%) 2
    Tendonitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Tenosynovitis 1/1710 (0.1%) 2 3/1705 (0.2%) 6
    Tenosynovitis stenosans 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Trigger finger 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Vertebral foraminal stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Adenocarcinoma gastric 4/1710 (0.2%) 6 0/1705 (0%) 0
    Adenocarcinoma of colon 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Adenocarcinoma pancreas 0/1710 (0%) 0 1/1705 (0.1%) 2
    Adenoma benign 2/1710 (0.1%) 4 0/1705 (0%) 0
    Adrenal adenoma 2/1710 (0.1%) 3 0/1705 (0%) 0
    Angiomyolipoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Angiosarcoma 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    B-cell lymphoma 2/1710 (0.1%) 3 2/1705 (0.1%) 3
    B-cell small lymphocytic lymphoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Basal cell carcinoma 8/1710 (0.5%) 19 2/1705 (0.1%) 4
    Benign breast neoplasm 0/1710 (0%) 0 1/1705 (0.1%) 2
    Bladder cancer 4/1710 (0.2%) 6 0/1705 (0%) 0
    Bladder papilloma 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Bladder transitional cell carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Bowen's disease 0/1710 (0%) 0 2/1705 (0.1%) 4
    Breast angiosarcoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Breast cancer 13/1710 (0.8%) 22 2/1705 (0.1%) 3
    Breast cancer female 0/1710 (0%) 0 1/1705 (0.1%) 2
    Breast cancer in situ 1/1710 (0.1%) 1 0/1705 (0%) 0
    Breast cancer metastatic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Breast cancer recurrent 2/1710 (0.1%) 4 0/1705 (0%) 0
    Breast neoplasm 2/1710 (0.1%) 4 0/1705 (0%) 0
    Bronchial carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Carcinoid tumour of the caecum 1/1710 (0.1%) 1 0/1705 (0%) 0
    Carcinoid tumour of the stomach 1/1710 (0.1%) 2 0/1705 (0%) 0
    Cardiac neoplasm unspecified 0/1710 (0%) 0 1/1705 (0.1%) 2
    Cholesteatoma 0/1710 (0%) 0 1/1705 (0.1%) 1
    Chronic lymphocytic leukaemia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Chronic myeloid leukaemia 0/1710 (0%) 0 1/1705 (0.1%) 2
    Clear cell renal cell carcinoma 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Colon adenoma 2/1710 (0.1%) 4 3/1705 (0.2%) 5
    Colon cancer 3/1710 (0.2%) 8 4/1705 (0.2%) 7
    Diffuse large b-cell lymphoma stage i 1/1710 (0.1%) 1 0/1705 (0%) 0
    Enchondromatosis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Endometrial adenocarcinoma 2/1710 (0.1%) 6 0/1705 (0%) 0
    Endometrial cancer 1/1710 (0.1%) 2 0/1705 (0%) 0
    Essential thrombocythaemia 0/1710 (0%) 0 1/1705 (0.1%) 2
    Fallopian tube cancer 1/1710 (0.1%) 2 0/1705 (0%) 0
    Fallopian tube cancer metastatic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Fibroma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Gallbladder cancer 1/1710 (0.1%) 2 0/1705 (0%) 0
    Gastric cancer 0/1710 (0%) 0 1/1705 (0.1%) 2
    Gastric neoplasm 1/1710 (0.1%) 2 0/1705 (0%) 0
    Glioblastoma multiforme 1/1710 (0.1%) 2 0/1705 (0%) 0
    Glomus tumour 0/1710 (0%) 0 1/1705 (0.1%) 1
    Haemangioma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Haemangioma of breast 0/1710 (0%) 0 1/1705 (0.1%) 2
    Hodgkin's disease 1/1710 (0.1%) 2 0/1705 (0%) 0
    Intra-abdominal haemangioma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intraductal proliferative breast lesion 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Invasive breast carcinoma 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Invasive ductal breast carcinoma 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Invasive lobular breast carcinoma 1/1710 (0.1%) 1 0/1705 (0%) 0
    Leiomyoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Lipoma 0/1710 (0%) 0 3/1705 (0.2%) 6
    Lung adenocarcinoma 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lung neoplasm 1/1710 (0.1%) 2 0/1705 (0%) 0
    Lung neoplasm malignant 1/1710 (0.1%) 2 0/1705 (0%) 0
    Malignant melanoma 6/1710 (0.4%) 12 3/1705 (0.2%) 4
    Malignant melanoma stage iv 1/1710 (0.1%) 2 0/1705 (0%) 0
    Malignant neoplasm of uterine adnexa 1/1710 (0.1%) 1 0/1705 (0%) 0
    Malignant peritoneal neoplasm 0/1710 (0%) 0 2/1705 (0.1%) 3
    Meningeal neoplasm 1/1710 (0.1%) 2 0/1705 (0%) 0
    Meningioma 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Mesothelioma malignant 1/1710 (0.1%) 2 0/1705 (0%) 0
    Metastases to abdominal cavity 1/1710 (0.1%) 2 0/1705 (0%) 0
    Metastases to bone 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Metastases to breast 1/1710 (0.1%) 2 0/1705 (0%) 0
    Metastases to central nervous system 1/1710 (0.1%) 2 0/1705 (0%) 0
    Metastases to liver 2/1710 (0.1%) 4 0/1705 (0%) 0
    Metastases to lung 2/1710 (0.1%) 2 1/1705 (0.1%) 1
    Metastases to lymph nodes 0/1710 (0%) 0 1/1705 (0.1%) 1
    Metastasis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Metastatic bronchial carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Mucinous breast carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 1
    Myelodysplastic syndrome 1/1710 (0.1%) 2 0/1705 (0%) 0
    Neoplasm 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Neoplasm malignant 1/1710 (0.1%) 1 0/1705 (0%) 0
    Neoplasm skin 0/1710 (0%) 0 1/1705 (0.1%) 2
    Neuroendocrine carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Neuroendocrine tumour 0/1710 (0%) 0 1/1705 (0.1%) 2
    Non-hodgkin's lymphoma 2/1710 (0.1%) 3 1/1705 (0.1%) 2
    Oral fibroma 2/1710 (0.1%) 4 0/1705 (0%) 0
    Osteochondroma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ovarian adenoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ovarian cancer 2/1710 (0.1%) 4 3/1705 (0.2%) 5
    Pancreatic carcinoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Pancreatic carcinoma metastatic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Papillary thyroid cancer 1/1710 (0.1%) 2 0/1705 (0%) 0
    Parathyroid tumour benign 2/1710 (0.1%) 4 0/1705 (0%) 0
    Plasma cell myeloma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Rectal adenocarcinoma 1/1710 (0.1%) 2 0/1705 (0%) 0
    Rectal adenoma 0/1710 (0%) 0 1/1705 (0.1%) 2
    Rectal cancer 1/1710 (0.1%) 1 0/1705 (0%) 0
    Renal cancer 1/1710 (0.1%) 2 0/1705 (0%) 0
    Renal cell carcinoma 1/1710 (0.1%) 1 0/1705 (0%) 0
    Rosai-dorfman syndrome 1/1710 (0.1%) 2 0/1705 (0%) 0
    Sarcoma uterus 2/1710 (0.1%) 4 0/1705 (0%) 0
    Skin papilloma 2/1710 (0.1%) 4 0/1705 (0%) 0
    Small intestine adenocarcinoma 1/1710 (0.1%) 1 0/1705 (0%) 0
    Squamous cell carcinoma 4/1710 (0.2%) 6 0/1705 (0%) 0
    Squamous cell carcinoma of lung 1/1710 (0.1%) 2 0/1705 (0%) 0
    Squamous cell carcinoma of skin 0/1710 (0%) 0 1/1705 (0.1%) 2
    Squamous cell carcinoma of the cervix 0/1710 (0%) 0 2/1705 (0.1%) 4
    Superficial spreading melanoma stage ii 1/1710 (0.1%) 1 0/1705 (0%) 0
    Superficial spreading melanoma stage unspecified 0/1710 (0%) 0 1/1705 (0.1%) 2
    Thyroid adenoma 3/1710 (0.2%) 5 0/1705 (0%) 0
    Thyroid cancer 2/1710 (0.1%) 4 0/1705 (0%) 0
    Tongue neoplasm benign 1/1710 (0.1%) 1 0/1705 (0%) 0
    Transitional cell carcinoma 2/1710 (0.1%) 4 0/1705 (0%) 0
    Uterine leiomyoma 6/1710 (0.4%) 15 1/1705 (0.1%) 1
    Nervous system disorders
    Ataxia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Autonomic nervous system imbalance 0/1710 (0%) 0 1/1705 (0.1%) 1
    Brain stem infarction 1/1710 (0.1%) 2 0/1705 (0%) 0
    Burning feet syndrome 1/1710 (0.1%) 2 0/1705 (0%) 0
    Carotid artery aneurysm 0/1710 (0%) 0 1/1705 (0.1%) 2
    Carotid artery stenosis 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Carpal tunnel syndrome 10/1710 (0.6%) 18 10/1705 (0.6%) 23
    Cerebral haemorrhage 2/1710 (0.1%) 4 0/1705 (0%) 0
    Cerebral infarction 3/1710 (0.2%) 5 2/1705 (0.1%) 5
    Cerebral ischaemia 2/1710 (0.1%) 3 1/1705 (0.1%) 2
    Cerebrovascular accident 5/1710 (0.3%) 12 1/1705 (0.1%) 2
    Cervical radiculopathy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Cervicobrachial syndrome 4/1710 (0.2%) 8 1/1705 (0.1%) 2
    Dementia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Dizziness 1/1710 (0.1%) 2 2/1705 (0.1%) 7
    Dysaesthesia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Embolic cerebral infarction 1/1710 (0.1%) 2 0/1705 (0%) 0
    Epilepsy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Facial paralysis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Generalised tonic-clonic seizure 0/1710 (0%) 0 1/1705 (0.1%) 2
    Haemorrhage intracranial 0/1710 (0%) 0 1/1705 (0.1%) 1
    Headache 2/1710 (0.1%) 4 0/1705 (0%) 0
    Hemiparesis 1/1710 (0.1%) 2 1/1705 (0.1%) 4
    Horner's syndrome 1/1710 (0.1%) 1 0/1705 (0%) 0
    Hypertonia 1/1710 (0.1%) 2 1/1705 (0.1%) 1
    Hypoaesthesia 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intracranial aneurysm 1/1710 (0.1%) 2 0/1705 (0%) 0
    Ischaemic cerebral infarction 0/1710 (0%) 0 1/1705 (0.1%) 2
    Lumbar radiculopathy 0/1710 (0%) 0 1/1705 (0.1%) 4
    Memory impairment 1/1710 (0.1%) 1 0/1705 (0%) 0
    Mental impairment 1/1710 (0.1%) 2 0/1705 (0%) 0
    Myelopathy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Nerve root compression 0/1710 (0%) 0 1/1705 (0.1%) 2
    Neuromuscular blockade 1/1710 (0.1%) 2 0/1705 (0%) 0
    Paraesthesia 2/1710 (0.1%) 4 0/1705 (0%) 0
    Paralysis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Parkinson's disease 0/1710 (0%) 0 2/1705 (0.1%) 4
    Partial seizures 1/1710 (0.1%) 1 0/1705 (0%) 0
    Peroneal nerve palsy 1/1710 (0.1%) 2 3/1705 (0.2%) 4
    Polyneuropathy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Quadriparesis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Radicular pain 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Ruptured cerebral aneurysm 0/1710 (0%) 0 1/1705 (0.1%) 2
    Sciatica 10/1710 (0.6%) 20 9/1705 (0.5%) 17
    Speech disorder 1/1710 (0.1%) 1 0/1705 (0%) 0
    Spinal cord compression 0/1710 (0%) 0 1/1705 (0.1%) 2
    Syncope 9/1710 (0.5%) 17 3/1705 (0.2%) 5
    Tension headache 0/1710 (0%) 0 1/1705 (0.1%) 2
    Thalamic infarction 2/1710 (0.1%) 4 0/1705 (0%) 0
    Transient ischaemic attack 8/1710 (0.5%) 15 2/1705 (0.1%) 2
    Trigeminal neuralgia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Vertigo cns origin 1/1710 (0.1%) 2 0/1705 (0%) 0
    Visual pathway disorder 0/1710 (0%) 0 1/1705 (0.1%) 1
    Vocal cord paresis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Product Issues
    Device breakage 0/1710 (0%) 0 1/1705 (0.1%) 1
    Psychiatric disorders
    Adjustment disorder with depressed mood 0/1710 (0%) 0 2/1705 (0.1%) 6
    Anxiety disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Bipolar disorder 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Burnout syndrome 0/1710 (0%) 0 1/1705 (0.1%) 2
    Completed suicide 0/1710 (0%) 0 2/1705 (0.1%) 3
    Depression 7/1710 (0.4%) 13 6/1705 (0.4%) 12
    Insomnia 1/1710 (0.1%) 2 0/1705 (0%) 0
    Intentional self-injury 0/1710 (0%) 0 1/1705 (0.1%) 2
    Major depression 1/1710 (0.1%) 4 0/1705 (0%) 0
    Mental disorder 0/1710 (0%) 0 1/1705 (0.1%) 1
    Panic attack 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Persistent depressive disorder 2/1710 (0.1%) 3 0/1705 (0%) 0
    Schizoaffective disorder 0/1710 (0%) 0 1/1705 (0.1%) 2
    Schizoaffective disorder depressive type 0/1710 (0%) 0 1/1705 (0.1%) 6
    Somatic symptom disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Haematuria 3/1710 (0.2%) 5 2/1705 (0.1%) 4
    Hydronephrosis 2/1710 (0.1%) 4 0/1705 (0%) 0
    Micturition disorder 0/1710 (0%) 0 1/1705 (0.1%) 1
    Nephrolithiasis 2/1710 (0.1%) 3 3/1705 (0.2%) 6
    Renal aneurysm 1/1710 (0.1%) 2 0/1705 (0%) 0
    Renal artery stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Renal colic 2/1710 (0.1%) 3 1/1705 (0.1%) 2
    Renal cyst 2/1710 (0.1%) 4 0/1705 (0%) 0
    Renal failure 3/1710 (0.2%) 6 2/1705 (0.1%) 4
    Renal mass 1/1710 (0.1%) 1 0/1705 (0%) 0
    Renal pain 0/1710 (0%) 0 1/1705 (0.1%) 1
    Stress urinary incontinence 2/1710 (0.1%) 4 1/1705 (0.1%) 1
    Ureteric stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Urethral haemorrhage 1/1710 (0.1%) 1 0/1705 (0%) 0
    Urethral stenosis 1/1710 (0.1%) 1 0/1705 (0%) 0
    Urinary incontinence 4/1710 (0.2%) 8 1/1705 (0.1%) 2
    Urinary retention 0/1710 (0%) 0 1/1705 (0.1%) 2
    Reproductive system and breast disorders
    Adenomyosis 1/1710 (0.1%) 2 1/1705 (0.1%) 6
    Adnexa uteri cyst 2/1710 (0.1%) 5 2/1705 (0.1%) 3
    Breast calcifications 5/1710 (0.3%) 10 4/1705 (0.2%) 6
    Breast disorder 2/1710 (0.1%) 4 0/1705 (0%) 0
    Breast fibrosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Breast hyperplasia 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Breast mass 2/1710 (0.1%) 3 1/1705 (0.1%) 1
    Breast necrosis 1/1710 (0.1%) 1 1/1705 (0.1%) 2
    Cervical dysplasia 2/1710 (0.1%) 4 0/1705 (0%) 0
    Cervical polyp 1/1710 (0.1%) 2 0/1705 (0%) 0
    Colpocele 0/1710 (0%) 0 2/1705 (0.1%) 3
    Cystocele 3/1710 (0.2%) 6 2/1705 (0.1%) 4
    Ectropion of cervix 0/1710 (0%) 0 1/1705 (0.1%) 4
    Endometrial atrophy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Endometrial disorder 4/1710 (0.2%) 12 0/1705 (0%) 0
    Endometrial hyperplasia 16/1710 (0.9%) 39 6/1705 (0.4%) 16
    Endometrial metaplasia 1/1710 (0.1%) 1 0/1705 (0%) 0
    Hydrometra 1/1710 (0.1%) 2 0/1705 (0%) 0
    Menometrorrhagia 0/1710 (0%) 0 1/1705 (0.1%) 3
    Menorrhagia 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Metrorrhagia 0/1710 (0%) 0 1/1705 (0.1%) 6
    Nipple exudate bloody 0/1710 (0%) 0 1/1705 (0.1%) 2
    Ovarian cyst 8/1710 (0.5%) 17 4/1705 (0.2%) 17
    Ovarian disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Pelvic pain 0/1710 (0%) 0 1/1705 (0.1%) 2
    Postmenopausal haemorrhage 11/1710 (0.6%) 22 9/1705 (0.5%) 19
    Rectocele 1/1710 (0.1%) 2 3/1705 (0.2%) 6
    Uterine disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Uterine polyp 16/1710 (0.9%) 51 6/1705 (0.4%) 17
    Uterine prolapse 2/1710 (0.1%) 4 2/1705 (0.1%) 4
    Uterovaginal prolapse 5/1710 (0.3%) 10 2/1705 (0.1%) 3
    Vaginal cyst 1/1710 (0.1%) 2 0/1705 (0%) 0
    Vaginal dysplasia 1/1710 (0.1%) 4 0/1705 (0%) 0
    Vaginal haemorrhage 1/1710 (0.1%) 2 7/1705 (0.4%) 12
    Vaginal polyp 2/1710 (0.1%) 3 1/1705 (0.1%) 4
    Vaginal prolapse 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Vaginal stricture 0/1710 (0%) 0 1/1705 (0.1%) 1
    Vulva cyst 0/1710 (0%) 0 1/1705 (0.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/1710 (0.1%) 1 0/1705 (0%) 0
    Bronchial polyp 1/1710 (0.1%) 2 0/1705 (0%) 0
    Bronchitis chronic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Chronic obstructive pulmonary disease 5/1710 (0.3%) 11 3/1705 (0.2%) 6
    Cough 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Dyspnoea 9/1710 (0.5%) 17 3/1705 (0.2%) 5
    Dyspnoea exertional 3/1710 (0.2%) 5 1/1705 (0.1%) 2
    Emphysema 1/1710 (0.1%) 2 0/1705 (0%) 0
    Epistaxis 4/1710 (0.2%) 4 0/1705 (0%) 0
    Haemoptysis 1/1710 (0.1%) 1 1/1705 (0.1%) 1
    Hyperventilation 0/1710 (0%) 0 1/1705 (0.1%) 1
    Hypoventilation 1/1710 (0.1%) 1 0/1705 (0%) 0
    Lung disorder 0/1710 (0%) 0 1/1705 (0.1%) 2
    Nasal turbinate abnormality 1/1710 (0.1%) 1 0/1705 (0%) 0
    Nocturnal dyspnoea 1/1710 (0.1%) 1 0/1705 (0%) 0
    Pleural effusion 3/1710 (0.2%) 7 1/1705 (0.1%) 2
    Pneumothorax 2/1710 (0.1%) 3 1/1705 (0.1%) 1
    Pulmonary artery thrombosis 0/1710 (0%) 0 1/1705 (0.1%) 4
    Pulmonary embolism 14/1710 (0.8%) 27 4/1705 (0.2%) 8
    Pulmonary oedema 0/1710 (0%) 0 1/1705 (0.1%) 2
    Pulmonary vascular disorder 1/1710 (0.1%) 2 0/1705 (0%) 0
    Respiratory failure 2/1710 (0.1%) 7 2/1705 (0.1%) 4
    Sinus disorder 1/1710 (0.1%) 1 0/1705 (0%) 0
    Sleep apnoea syndrome 2/1710 (0.1%) 3 0/1705 (0%) 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Angioedema 0/1710 (0%) 0 1/1705 (0.1%) 12
    Blister 1/1710 (0.1%) 1 0/1705 (0%) 0
    Decubitus ulcer 0/1710 (0%) 0 2/1705 (0.1%) 6
    Dermal cyst 0/1710 (0%) 0 1/1705 (0.1%) 4
    Dermatitis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Eczema 1/1710 (0.1%) 2 0/1705 (0%) 0
    Erythema 1/1710 (0.1%) 2 0/1705 (0%) 0
    Excessive granulation tissue 0/1710 (0%) 0 1/1705 (0.1%) 2
    Hidradenitis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Lichen sclerosus 0/1710 (0%) 0 1/1705 (0.1%) 1
    Petechiae 1/1710 (0.1%) 2 0/1705 (0%) 0
    Psoriasis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Sebaceous gland disorder 0/1710 (0%) 0 1/1705 (0.1%) 2
    Skin lesion 0/1710 (0%) 0 1/1705 (0.1%) 2
    Skin necrosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Skin ulcer 4/1710 (0.2%) 7 1/1705 (0.1%) 2
    Urticaria chronic 1/1710 (0.1%) 2 0/1705 (0%) 0
    Surgical and medical procedures
    Alcohol rehabilitation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Angioplasty 1/1710 (0.1%) 2 0/1705 (0%) 0
    Aortic valve replacement 1/1710 (0.1%) 3 0/1705 (0%) 0
    Arthrodesis 0/1710 (0%) 0 1/1705 (0.1%) 1
    Breast operation 0/1710 (0%) 0 1/1705 (0.1%) 1
    Breast reconstruction 0/1710 (0%) 0 1/1705 (0.1%) 1
    Bunion operation 2/1710 (0.1%) 3 0/1705 (0%) 0
    Cancer surgery 1/1710 (0.1%) 1 0/1705 (0%) 0
    Cardiac pacemaker insertion 1/1710 (0.1%) 1 0/1705 (0%) 0
    Cardiac pacemaker replacement 1/1710 (0.1%) 2 0/1705 (0%) 0
    Carpal tunnel decompression 1/1710 (0.1%) 1 0/1705 (0%) 0
    Cataract operation 2/1710 (0.1%) 6 3/1705 (0.2%) 5
    Central venous catheter removal 2/1710 (0.1%) 3 0/1705 (0%) 0
    Cholecystectomy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Colostomy 0/1710 (0%) 0 1/1705 (0.1%) 1
    Enterostomy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Eye operation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Gastric banding 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hernia repair 1/1710 (0.1%) 2 0/1705 (0%) 0
    Hip arthroplasty 1/1710 (0.1%) 2 4/1705 (0.2%) 6
    Hysterectomy 1/1710 (0.1%) 1 1/1705 (0.1%) 1
    Hysterosalpingo-oophorectomy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intraocular lens implant 2/1710 (0.1%) 6 0/1705 (0%) 0
    Jaw operation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Joint arthroplasty 2/1710 (0.1%) 2 1/1705 (0.1%) 2
    Knee arthroplasty 5/1710 (0.3%) 10 3/1705 (0.2%) 6
    Knee operation 1/1710 (0.1%) 1 0/1705 (0%) 0
    Large intestinal polypectomy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Lipoma excision 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Lithotripsy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Lymphadenectomy 0/1710 (0%) 0 1/1705 (0.1%) 1
    Mammoplasty 1/1710 (0.1%) 2 2/1705 (0.1%) 4
    Medical device removal 0/1710 (0%) 0 1/1705 (0.1%) 2
    Mole excision 1/1710 (0.1%) 2 0/1705 (0%) 0
    Nasal operation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Nephrectomy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Oophorectomy 0/1710 (0%) 0 1/1705 (0.1%) 2
    Oophorectomy bilateral 1/1710 (0.1%) 2 0/1705 (0%) 0
    Plastic surgery 1/1710 (0.1%) 2 0/1705 (0%) 0
    Posterior lens capsulotomy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Postoperative care 0/1710 (0%) 0 1/1705 (0.1%) 2
    Radioactive iodine therapy 1/1710 (0.1%) 1 0/1705 (0%) 0
    Rectal polypectomy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Renal cyst excision 1/1710 (0.1%) 1 0/1705 (0%) 0
    Salpingo-oophorectomy bilateral 1/1710 (0.1%) 2 0/1705 (0%) 0
    Scar excision 2/1710 (0.1%) 4 0/1705 (0%) 0
    Skin graft 1/1710 (0.1%) 2 0/1705 (0%) 0
    Spinal decompression 0/1710 (0%) 0 1/1705 (0.1%) 2
    Spinal operation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Synovectomy 0/1710 (0%) 0 1/1705 (0.1%) 1
    Synovial cyst removal 0/1710 (0%) 0 1/1705 (0.1%) 2
    Tendon operation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Thyreostatic therapy 1/1710 (0.1%) 2 0/1705 (0%) 0
    Thyroidectomy 2/1710 (0.1%) 3 0/1705 (0%) 0
    Toe operation 2/1710 (0.1%) 4 0/1705 (0%) 0
    Tooth extraction 1/1710 (0.1%) 1 0/1705 (0%) 0
    Uterine tumour excision 1/1710 (0.1%) 1 0/1705 (0%) 0
    Vaginoperineoplasty 1/1710 (0.1%) 1 0/1705 (0%) 0
    Varicose vein operation 0/1710 (0%) 0 1/1705 (0.1%) 2
    Vascular disorders
    Aortic aneurysm 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Aortic arteriosclerosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Aortic dissection 1/1710 (0.1%) 1 0/1705 (0%) 0
    Aortic stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Arteriosclerosis 1/1710 (0.1%) 2 1/1705 (0.1%) 2
    Blood pressure fluctuation 1/1710 (0.1%) 2 0/1705 (0%) 0
    Blood pressure inadequately controlled 1/1710 (0.1%) 2 0/1705 (0%) 0
    Circulatory collapse 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Deep vein thrombosis 7/1710 (0.4%) 15 3/1705 (0.2%) 5
    Embolism 0/1710 (0%) 0 1/1705 (0.1%) 2
    Embolism arterial 1/1710 (0.1%) 4 1/1705 (0.1%) 2
    Extrinsic iliac vein compression 1/1710 (0.1%) 1 0/1705 (0%) 0
    Haematoma 2/1710 (0.1%) 4 2/1705 (0.1%) 4
    Hypertension 8/1710 (0.5%) 14 6/1705 (0.4%) 10
    Hypertensive crisis 13/1710 (0.8%) 27 1/1705 (0.1%) 2
    Iliac artery occlusion 0/1710 (0%) 0 1/1705 (0.1%) 2
    Intermittent claudication 1/1710 (0.1%) 4 0/1705 (0%) 0
    Lymphoedema 3/1710 (0.2%) 8 2/1705 (0.1%) 3
    Orthostatic hypotension 2/1710 (0.1%) 3 0/1705 (0%) 0
    Peripheral arterial occlusive disease 2/1710 (0.1%) 4 1/1705 (0.1%) 2
    Peripheral artery occlusion 0/1710 (0%) 0 1/1705 (0.1%) 2
    Peripheral artery stenosis 2/1710 (0.1%) 4 0/1705 (0%) 0
    Peripheral venous disease 0/1710 (0%) 0 4/1705 (0.2%) 8
    Subclavian artery stenosis 1/1710 (0.1%) 2 0/1705 (0%) 0
    Temporal arteritis 0/1710 (0%) 0 1/1705 (0.1%) 2
    Thrombosis 3/1710 (0.2%) 8 1/1705 (0.1%) 1
    Varicose vein 8/1710 (0.5%) 15 12/1705 (0.7%) 27
    Vasculitis 0/1710 (0%) 0 1/1705 (0.1%) 3
    Vein disorder 0/1710 (0%) 0 1/1705 (0.1%) 1
    Venous thrombosis 4/1710 (0.2%) 6 0/1705 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm B: Anastrozol - 1 mg Per Day for 5 Years Arm A: Anastrozol - 1 mg Per Day for 2 Years
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1710 (0%) 0/1705 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    PI/Sponsor collaborate in good faith regarding contents/formation of any PI publication/disclosure; PI pays due consideration to comments/opinions of Sponsor. Prior to any publication PI undertakes to provide Sponsor with preliminary data and drafts of publication/disclosures (oral or written) and with proposed final manuscript. Sponsor can review within 30 days and can require that submission for publication/disclosure of manuscript be delayed in order for Sponsor to file patent applications.

    Results Point of Contact

    Name/Title Trial Office Director
    Organization ABCSG
    Phone +43 1 4089230
    Email info@abcsg.at
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00295620
    Other Study ID Numbers:
    • 1033AU/0003
    • ABCSG 16
    • D5392L00016
    • SALSA
    First Posted:
    Feb 24, 2006
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Oct 1, 2019