FACE: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00248170
Collaborator
(none)
4,172
263
2
105
15.9
0.2
Study Details
Study Description
Brief Summary
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Letrozole 2.5 mg by mouth (p.o.) once daily |
Drug: Letrozole
2.5 mg tablets
|
| Active Comparator: Anastrozole 1 mg p.o. once daily |
Drug: Anastrozole
1 mg tablets
|
Outcome Measures
Primary Outcome Measures
- Disease Free Survival [84 months]
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
Secondary Outcome Measures
- Overall Survival [84 months]
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
- Time to Development of Distant Metastases [84 months]
Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
- Time to Development of Contra Lateral Breast Cancer [84 months]
Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
- Distant Disease-free Survival [84 months]
Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
- Change From Baseline in Serum Lipid Profiles [baseline, 6, 12, 24, 36, 48 and 60 months]
Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
- Percentage of Participants Who Experienced Clinical Fracture Events [84 months]
The incidence of clinical fractures was analyzed.
- Percentage of Participants Who Experienced Cardiovascular Events [84 months]
The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
33 Years
to 96 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Recent primary surgery for breast cancer
-
Early stage breast cancer
-
Postmenopausal
-
Hormone receptor positive
-
Positive lymph node involvement
Exclusion Criteria:
-
Metastatic disease
-
Presence of contralateral breast cancer including DCIS
-
Progression
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham Hematology and Oncology Associates | Birmingham | Alabama | United States | 35205 |
| 2 | Comprehensive Cancer Institute | Huntsville | Alabama | United States | 35801 |
| 3 | Northern Arizona Hematology/Oncology Associates, P.C. | Flagstaff | Arizona | United States | 86001 |
| 4 | Oncology & Hematology Associates, PC | New London | Connecticut | United States | 06320 |
| 5 | Florida Cancer Specialists | Fort Meyers | Florida | United States | 33901 |
| 6 | Sarah Cannon Research Institute | Jacksonville | Florida | United States | 32256 |
| 7 | Cancer Centers of Florida PA | Ocoee | Florida | United States | 34761 |
| 8 | Florida Cancer Institute | Orlando | Florida | United States | 32804 |
| 9 | Gulfcoast Oncology Associates | St. Petersburg | Florida | United States | 33705 |
| 10 | University Cancer & Blood Center, LLC | Athens | Georgia | United States | 30607 |
| 11 | Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46227 |
| 12 | Kansas City Cancer Center | Overland Park | Kansas | United States | 66210 |
| 13 | Wichita Community Clinical Oncology Program | Wichita | Kansas | United States | 67214 |
| 14 | Center for Cancer & Blood Disorders | Bethesda | Maryland | United States | 20817 |
| 15 | St. Louis Cancer & Breast Institute | St. Louis | Missouri | United States | 63141 |
| 16 | New York Oncology Hematology, P.C. NYOH Latham | Troy | New York | United States | 12180 |
| 17 | Raleigh Hematology Oncology Associates | Cary | North Carolina | United States | 27511 |
| 18 | Aultman Cancer Center | Canton | Ohio | United States | 44710 |
| 19 | Sarah Cannon Oncology Hematology Care, Inc | Cincinnati | Ohio | United States | 45242 |
| 20 | Oncology Associates of Oregon, PC | Eugene | Oregon | United States | 97401-8122 |
| 21 | Medical Oncology Associates of Wyorning Valley, PC | Kingston | Pennsylvania | United States | 18704 |
| 22 | Chattanooga Oncology and Hematology Assoicates, PC | Chattanooga | Tennessee | United States | 37404 |
| 23 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 24 | Texas Oncology, P.A. | Bedford | Texas | United States | 76022 |
| 25 | Center for Oncology Research and Treatment, PA | Dallas | Texas | United States | 75230 |
| 26 | Texas Cancer Center ( Medical City Dallas Hospital) | Dallas | Texas | United States | 75230 |
| 27 | Texas Oncology Presbyterian Hospital | Dallas | Texas | United States | 75246 |
| 28 | Texas Oncology Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 29 | Texas Oncology Texas Oncology PA | Dallas | Texas | United States | 75251 |
| 30 | Texas Cancer Center Denton | Denton | Texas | United States | 76210 |
| 31 | El Paso Cancer Treatment Ctr-East | El Paso | Texas | United States | 79915 |
| 32 | Texas Oncology, P.A. | Fort Worth | Texas | United States | 76104 |
| 33 | San Antonio Tumor and Blood Clinic | Fredericksburg | Texas | United States | 78624 |
| 34 | MD Anderson Cancer Center/University of Texas | Houston | Texas | United States | 77030 |
| 35 | Longview Cancer Center | Longview | Texas | United States | 75601 |
| 36 | South Texas Cancer Center- McAllen | McAllen | Texas | United States | 78503 |
| 37 | Allison Cancer Center | Midland | Texas | United States | 79701-5946 |
| 38 | Texas Cancer Center- Sherman | Sherman | Texas | United States | 75090-0504 |
| 39 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 40 | Waco Cancer and Research Center | Waco | Texas | United States | 76712 |
| 41 | Virginia Cancer Specialists, PC | Fairfax | Virginia | United States | 22031 |
| 42 | Northwest Cancer Specialists, P.C. | Vancover | Washington | United States | 98664 |
| 43 | Novartis Investigative Site | Garran | Australian Capital Territory | Australia | 2605 |
| 44 | Novartis Investigative Site | Port Macquarie | New South Wales | Australia | 2444 |
| 45 | Novartis Investigative Site | Randwick | New South Wales | Australia | 2031 |
| 46 | Novartis Investigative Site | Sydney | New South Wales | Australia | 2060 |
| 47 | Novartis Investigative Site | Tweed Heads | New South Wales | Australia | 2485 |
| 48 | Novartis Investigative Site | Waratah | New South Wales | Australia | 2298 |
| 49 | Novartis Investigative Site | Nambour | Queensland | Australia | 4560 |
| 50 | Novartis Investigative Site | Redcliff | Queensland | Australia | 4020 |
| 51 | Novartis Investigative Site | Adelaide | South Australia | Australia | 5000 |
| 52 | Novartis Investigative Site | Toorak Gardens | South Australia | Australia | 5065 |
| 53 | Novartis Investigative Site | Box Hill | Victoria | Australia | 3128 |
| 54 | Novartis Investigative Site | East Bentleigh | Victoria | Australia | 3165 |
| 55 | Novartis Investigative Site | Epping | Victoria | Australia | 3076 |
| 56 | Novartis Investigative Site | Footscray | Victoria | Australia | 3011 |
| 57 | Novartis Investigative Site | Franston | Victoria | Australia | 3199 |
| 58 | Novartis Investigative Site | Malvern | Victoria | Australia | 3144 |
| 59 | Novartis Investigative Site | Parkville | Victoria | Australia | 3050 |
| 60 | Novartis Investigative Site | Wodonga | Victoria | Australia | 3690 |
| 61 | Novartis Investigative Site | Nedlands | Western Australia | Australia | 6009 |
| 62 | Novartis Investigative Site | Perth | Western Australia | Australia | 6000 |
| 63 | Novartis Investigative Site | Perth | Western Australia | Australia | 6005 |
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| 72 | Novartis Investigative Site | Innsbruck | Austria | 6020 | |
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| 127 | Novartis Investigative Site | Perpignan | France | 66000 | |
| 128 | Novartis Investigative Site | Périgueux Cédex | France | 24004 | |
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| 130 | Novartis Investigative Site | Strasbourg | France | 67091 | |
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| 132 | Novartis Investigative Site | Amberg | Germany | 92224 | |
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| 134 | Novartis Investigative Site | Berlin | Germany | 10317 | |
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| 140 | Novartis Investigative Site | Bremen | Germany | 28205 | |
| 141 | Novartis Investigative Site | Duesseldorf | Germany | 40225 | |
| 142 | Novartis Investigative Site | Erlangen | Germany | 91054 | |
| 143 | Novartis Investigative Site | Essen | Germany | 45147 | |
| 144 | Novartis Investigative Site | Frankfurt | Germany | 65929 | |
| 145 | Novartis Investigative Site | Freiburg | Germany | 79106 | |
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| 150 | Novartis Investigative Site | Homburg | Germany | 66421 | |
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| 178 | Novartis Investigative Site | Tel-Aviv | Israel | 6423906 | |
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| 180 | Novartis Investigative Site | Montevarchi | AR | Italy | 52025 |
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| 220 | Novartis Investigative Site | Goyang | Gyeonggi-do | Korea, Republic of | 410-769 |
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| 223 | Novartis Investigative Site | Eindhoven | Netherlands | 5623 EJ | |
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| 235 | Novartis Investigative Site | La Coruna | Galicia | Spain | 15006 |
| 236 | Novartis Investigative Site | Alicante | Spain | 03010 | |
| 237 | Novartis Investigative Site | Madrid | Spain | 28040 | |
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| 242 | Novartis Investigative Site | Chur | Switzerland | 7000 | |
| 243 | Novartis Investigative Site | Luzern | Switzerland | 6000 | |
| 244 | Novartis Investigative Site | Schaffhausen | Switzerland | 8208 | |
| 245 | Novartis Investigative Site | Winterthur | Switzerland | 8401 | |
| 246 | Novartis Investigative Site | Hull | East Yorkshire | United Kingdom | HU8 9HE |
| 247 | Novartis Investigative Site | Northwood | Middlesex | United Kingdom | HA6 2RN |
| 248 | Novartis Investigative Site | Belfast | United Kingdom | BT9 7AB | |
| 249 | Novartis Investigative Site | Bournemouth | United Kingdom | BH7 7DW | |
| 250 | Novartis Investigative Site | Bristol | United Kingdom | BS16 1JE | |
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| 256 | Novartis Investigative Site | London | United Kingdom | NW3 2QG | |
| 257 | Novartis Investigative Site | Manchester | United Kingdom | M23 9LT | |
| 258 | Novartis Investigative Site | Merseyside | United Kingdom | L63 4JY | |
| 259 | Novartis Investigative Site | Plymouth | United Kingdom | PL6 8DH | |
| 260 | Novartis Investigative Site | Rhyl | United Kingdom | LL18 5UJ | |
| 261 | Novartis Investigative Site | Sheffiled | United Kingdom | S10 2SJ | |
| 262 | Novartis Investigative Site | Shrewsbury | United Kingdom | SY38XQ | |
| 263 | Novartis Investigative Site | Surrey | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00248170
Other Study ID Numbers:
- CFEM345D2411
- 2005-004263-35
- EUDRACT number 2005-004263-35
First Posted:
Nov 3, 2005
Last Update Posted:
Apr 19, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants, who had recently undergone surgery, were randomly assigned in 1:1 ratio to letrozole or anastrozole. Participants received daily treatment until disease recurrence/relapse or for a maximum of 5 years. Participants underwent post-treatment long term follow-up for disease-free survival and overall survival. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Period Title: Overall Study | ||
| STARTED | 2078 | 2094 |
| Intent-to-treat (ITT) | 2061 | 2075 |
| Safety Set | 2049 | 2062 |
| COMPLETED | 1317 | 1286 |
| NOT COMPLETED | 761 | 808 |
Baseline Characteristics
| Arm/Group Title | Letrozole | Anastrozole | Total |
|---|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily | Total of all reporting groups |
| Overall Participants | 2061 | 2075 | 4136 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
63.2
(8.48)
|
63.1
(8.45)
|
63.2
(8.46)
|
| Sex/Gender, Customized (Number) [Number] | |||
| Female |
2061
100%
|
2075
100%
|
4136
100%
|
Outcome Measures
| Title | Disease Free Survival |
|---|---|
| Description | Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2061 | 2075 |
| Median (95% Confidence Interval) [Months] |
NA
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Letrozole, Anastrozole |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3150 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Overall Survival |
|---|---|
| Description | Overall survival was defined as the time from the date of randomization to the date of death from any cause. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2061 | 2075 |
| Median (95% Confidence Interval) [Months] |
NA
|
NA
|
| Title | Time to Development of Distant Metastases |
|---|---|
| Description | Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2061 | 2075 |
| Median (95% Confidence Interval) [Months] |
NA
|
NA
|
| Title | Time to Development of Contra Lateral Breast Cancer |
|---|---|
| Description | Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2061 | 2075 |
| Median (95% Confidence Interval) [Months] |
NA
|
NA
|
| Title | Distant Disease-free Survival |
|---|---|
| Description | Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2061 | 2075 |
| Median (95% Confidence Interval) [Months] |
NA
|
NA
|
| Title | Change From Baseline in Serum Lipid Profiles |
|---|---|
| Description | Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated. |
| Time Frame | baseline, 6, 12, 24, 36, 48 and 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2049 | 2062 |
| 6 months |
5.643
|
5.553
|
| 12 months |
5.569
|
5.511
|
| 24 months |
5.508
|
5.436
|
| 36 months |
5.429
|
5.427
|
| 48 months |
5.395
|
5.366
|
| 60 months |
5.375
|
5.368
|
| Title | Percentage of Participants Who Experienced Clinical Fracture Events |
|---|---|
| Description | The incidence of clinical fractures was analyzed. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2049 | 2062 |
| Number [Percentage of participants] |
9.3
0.5%
|
8.1
0.4%
|
| Title | Percentage of Participants Who Experienced Cardiovascular Events |
|---|---|
| Description | The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed. |
| Time Frame | 84 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment. |
| Arm/Group Title | Letrozole | Anastrozole |
|---|---|---|
| Arm/Group Description | 2.5 mg by mouth (p.o.) once daily | 1 mg p.o. once daily |
| Measure Participants | 2049 | 2062 |
| Ischemic heart disease |
2.4
0.1%
|
1.5
0.1%
|
| Cardiac failures |
1.5
0.1%
|
0.7
0%
|
| Cerebrovascular accidents |
1.6
0.1%
|
1.5
0.1%
|
| Thromboembolic events |
1.2
0.1%
|
1.2
0.1%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Letrozole | Anastrozole | ||
| Arm/Group Description | Letrozole | Anastrozole | ||
All Cause Mortality |
||||
| Letrozole | Anastrozole | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Letrozole | Anastrozole | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 486/2049 (23.7%) | 520/2062 (25.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 4/2049 (0.2%) | 3/2062 (0.1%) | ||
| Autoimmune haemolytic anaemia | 0/2049 (0%) | 1/2062 (0%) | ||
| Haemorrhagic anaemia | 1/2049 (0%) | 0/2062 (0%) | ||
| Lymphadenopathy | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Pancytopenia | 0/2049 (0%) | 1/2062 (0%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/2049 (0%) | 1/2062 (0%) | ||
| Acute myocardial infarction | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Adams-Stokes syndrome | 1/2049 (0%) | 0/2062 (0%) | ||
| Angina pectoris | 8/2049 (0.4%) | 8/2062 (0.4%) | ||
| Angina unstable | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Arrhythmia | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Atrial fibrillation | 19/2049 (0.9%) | 15/2062 (0.7%) | ||
| Atrioventricular block complete | 1/2049 (0%) | 0/2062 (0%) | ||
| Bradycardia | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Bundle branch block | 1/2049 (0%) | 0/2062 (0%) | ||
| Cardiac arrest | 2/2049 (0.1%) | 4/2062 (0.2%) | ||
| Cardiac disorder | 1/2049 (0%) | 1/2062 (0%) | ||
| Cardiac failure | 9/2049 (0.4%) | 3/2062 (0.1%) | ||
| Cardiac failure acute | 1/2049 (0%) | 0/2062 (0%) | ||
| Cardiac failure chronic | 3/2049 (0.1%) | 0/2062 (0%) | ||
| Cardiac failure congestive | 9/2049 (0.4%) | 4/2062 (0.2%) | ||
| Cardiac fibrillation | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Cardiac tamponade | 1/2049 (0%) | 0/2062 (0%) | ||
| Cardiac valve disease | 0/2049 (0%) | 1/2062 (0%) | ||
| Cardio-respiratory arrest | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Cardiomyopathy | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Cardiovascular insufficiency | 1/2049 (0%) | 0/2062 (0%) | ||
| Conduction disorder | 0/2049 (0%) | 1/2062 (0%) | ||
| Congestive cardiomyopathy | 0/2049 (0%) | 1/2062 (0%) | ||
| Cor pulmonale | 1/2049 (0%) | 0/2062 (0%) | ||
| Coronary artery disease | 7/2049 (0.3%) | 2/2062 (0.1%) | ||
| Coronary artery stenosis | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Gastrocardiac syndrome | 1/2049 (0%) | 0/2062 (0%) | ||
| Ischaemic cardiomyopathy | 1/2049 (0%) | 0/2062 (0%) | ||
| Left ventricular dysfunction | 1/2049 (0%) | 1/2062 (0%) | ||
| Left ventricular failure | 0/2049 (0%) | 1/2062 (0%) | ||
| Mitral valve disease | 1/2049 (0%) | 0/2062 (0%) | ||
| Mitral valve incompetence | 1/2049 (0%) | 0/2062 (0%) | ||
| Myocardial infarction | 5/2049 (0.2%) | 4/2062 (0.2%) | ||
| Myocardial ischaemia | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Palpitations | 1/2049 (0%) | 1/2062 (0%) | ||
| Restrictive cardiomyopathy | 1/2049 (0%) | 0/2062 (0%) | ||
| Sick sinus syndrome | 0/2049 (0%) | 1/2062 (0%) | ||
| Stress cardiomyopathy | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Supraventricular tachycardia | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Tachyarrhythmia | 1/2049 (0%) | 0/2062 (0%) | ||
| Tachycardia | 3/2049 (0.1%) | 0/2062 (0%) | ||
| Tricuspid valve incompetence | 1/2049 (0%) | 1/2062 (0%) | ||
| Ventricular extrasystoles | 1/2049 (0%) | 0/2062 (0%) | ||
| Ventricular fibrillation | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Ventricular tachycardia | 0/2049 (0%) | 1/2062 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Atrial septal defect | 0/2049 (0%) | 1/2062 (0%) | ||
| Syndactyly | 0/2049 (0%) | 1/2062 (0%) | ||
| Vitello-intestinal duct remnant | 0/2049 (0%) | 1/2062 (0%) | ||
| Ear and labyrinth disorders | ||||
| Hearing impaired | 0/2049 (0%) | 1/2062 (0%) | ||
| Inner ear disorder | 1/2049 (0%) | 0/2062 (0%) | ||
| Tinnitus | 1/2049 (0%) | 0/2062 (0%) | ||
| Tympanic membrane perforation | 0/2049 (0%) | 1/2062 (0%) | ||
| Vertigo | 8/2049 (0.4%) | 1/2062 (0%) | ||
| Vertigo positional | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Endocrine disorders | ||||
| Autoimmune thyroiditis | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Goitre | 4/2049 (0.2%) | 2/2062 (0.1%) | ||
| Hyperparathyroidism | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Hypothyroidism | 1/2049 (0%) | 0/2062 (0%) | ||
| Toxic nodular goitre | 1/2049 (0%) | 1/2062 (0%) | ||
| Eye disorders | ||||
| Cataract | 9/2049 (0.4%) | 2/2062 (0.1%) | ||
| Dacryostenosis acquired | 1/2049 (0%) | 0/2062 (0%) | ||
| Diplopia | 0/2049 (0%) | 1/2062 (0%) | ||
| Glaucoma | 1/2049 (0%) | 1/2062 (0%) | ||
| Lens dislocation | 1/2049 (0%) | 0/2062 (0%) | ||
| Macular hole | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Open angle glaucoma | 1/2049 (0%) | 0/2062 (0%) | ||
| Retinal detachment | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Retinal vein thrombosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Vision blurred | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal adhesions | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Abdominal distension | 1/2049 (0%) | 1/2062 (0%) | ||
| Abdominal hernia | 1/2049 (0%) | 1/2062 (0%) | ||
| Abdominal pain | 9/2049 (0.4%) | 5/2062 (0.2%) | ||
| Abdominal pain lower | 1/2049 (0%) | 3/2062 (0.1%) | ||
| Abdominal pain upper | 6/2049 (0.3%) | 7/2062 (0.3%) | ||
| Abdominal wall haematoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Anal sphincter atony | 1/2049 (0%) | 0/2062 (0%) | ||
| Ascites | 0/2049 (0%) | 1/2062 (0%) | ||
| Colitis | 1/2049 (0%) | 1/2062 (0%) | ||
| Colitis ischaemic | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Colitis microscopic | 1/2049 (0%) | 0/2062 (0%) | ||
| Colitis ulcerative | 1/2049 (0%) | 0/2062 (0%) | ||
| Constipation | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Crohn's disease | 0/2049 (0%) | 1/2062 (0%) | ||
| Diarrhoea | 8/2049 (0.4%) | 5/2062 (0.2%) | ||
| Diverticulum | 0/2049 (0%) | 1/2062 (0%) | ||
| Diverticulum intestinal | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Duodenal ulcer | 1/2049 (0%) | 1/2062 (0%) | ||
| Duodenal ulcer haemorrhage | 0/2049 (0%) | 1/2062 (0%) | ||
| Dyspepsia | 0/2049 (0%) | 1/2062 (0%) | ||
| Dysphagia | 0/2049 (0%) | 1/2062 (0%) | ||
| Enterocutaneous fistula | 0/2049 (0%) | 1/2062 (0%) | ||
| Enterovesical fistula | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Faecal incontinence | 0/2049 (0%) | 1/2062 (0%) | ||
| Faeces discoloured | 0/2049 (0%) | 1/2062 (0%) | ||
| Femoral hernia | 0/2049 (0%) | 1/2062 (0%) | ||
| Gastric haemorrhage | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastric polyps | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastric ulcer | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Gastric ulcer haemorrhage | 0/2049 (0%) | 1/2062 (0%) | ||
| Gastric ulcer perforation | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastritis | 3/2049 (0.1%) | 5/2062 (0.2%) | ||
| Gastritis erosive | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Gastrointestinal disorder | 1/2049 (0%) | 1/2062 (0%) | ||
| Gastrointestinal haemorrhage | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Gastrooesophageal reflux disease | 0/2049 (0%) | 1/2062 (0%) | ||
| Haematemesis | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Haematochezia | 1/2049 (0%) | 1/2062 (0%) | ||
| Haemorrhoids | 1/2049 (0%) | 1/2062 (0%) | ||
| Hiatus hernia | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Ileus | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Ileus paralytic | 1/2049 (0%) | 0/2062 (0%) | ||
| Inflammatory bowel disease | 1/2049 (0%) | 1/2062 (0%) | ||
| Inguinal hernia | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Intestinal dilatation | 0/2049 (0%) | 1/2062 (0%) | ||
| Intestinal obstruction | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Intestinal perforation | 1/2049 (0%) | 0/2062 (0%) | ||
| Intestinal polyp | 0/2049 (0%) | 1/2062 (0%) | ||
| Large intestine polyp | 7/2049 (0.3%) | 2/2062 (0.1%) | ||
| Melaena | 1/2049 (0%) | 0/2062 (0%) | ||
| Mouth cyst | 1/2049 (0%) | 0/2062 (0%) | ||
| Nausea | 11/2049 (0.5%) | 6/2062 (0.3%) | ||
| Oesophagitis | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Pancreatitis | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Pancreatitis acute | 0/2049 (0%) | 1/2062 (0%) | ||
| Rectal haemorrhage | 2/2049 (0.1%) | 5/2062 (0.2%) | ||
| Small intestinal obstruction | 2/2049 (0.1%) | 3/2062 (0.1%) | ||
| Spigelian hernia | 1/2049 (0%) | 0/2062 (0%) | ||
| Stomatitis | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Subileus | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Tooth loss | 0/2049 (0%) | 1/2062 (0%) | ||
| Umbilical hernia | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Volvulus | 0/2049 (0%) | 1/2062 (0%) | ||
| Vomiting | 11/2049 (0.5%) | 6/2062 (0.3%) | ||
| General disorders | ||||
| Asthenia | 0/2049 (0%) | 6/2062 (0.3%) | ||
| Cardiac death | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Chest discomfort | 0/2049 (0%) | 1/2062 (0%) | ||
| Chest pain | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Death | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Device damage | 1/2049 (0%) | 0/2062 (0%) | ||
| Device dislocation | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Device malfunction | 0/2049 (0%) | 1/2062 (0%) | ||
| Disease progression | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Disease recurrence | 0/2049 (0%) | 1/2062 (0%) | ||
| Drowning | 0/2049 (0%) | 1/2062 (0%) | ||
| Fat necrosis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Fatigue | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Gait disturbance | 0/2049 (0%) | 2/2062 (0.1%) | ||
| General physical health deterioration | 4/2049 (0.2%) | 3/2062 (0.1%) | ||
| Impaired healing | 1/2049 (0%) | 1/2062 (0%) | ||
| Implant site extravasation | 1/2049 (0%) | 0/2062 (0%) | ||
| Injection site phlebitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Malaise | 2/2049 (0.1%) | 3/2062 (0.1%) | ||
| Multi-organ failure | 1/2049 (0%) | 1/2062 (0%) | ||
| Non-cardiac chest pain | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Oedema peripheral | 0/2049 (0%) | 1/2062 (0%) | ||
| Pain | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Patient-device incompatibility | 0/2049 (0%) | 1/2062 (0%) | ||
| Pyrexia | 2/2049 (0.1%) | 8/2062 (0.4%) | ||
| Sudden death | 0/2049 (0%) | 1/2062 (0%) | ||
| Thrombosis in device | 1/2049 (0%) | 0/2062 (0%) | ||
| Hepatobiliary disorders | ||||
| Biliary colic | 0/2049 (0%) | 1/2062 (0%) | ||
| Cholecystitis | 7/2049 (0.3%) | 5/2062 (0.2%) | ||
| Cholecystitis acute | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Cholecystitis chronic | 0/2049 (0%) | 1/2062 (0%) | ||
| Cholelithiasis | 8/2049 (0.4%) | 11/2062 (0.5%) | ||
| Cholestasis | 0/2049 (0%) | 1/2062 (0%) | ||
| Gallbladder perforation | 0/2049 (0%) | 1/2062 (0%) | ||
| Gallbladder polyp | 1/2049 (0%) | 0/2062 (0%) | ||
| Hepatic cirrhosis | 1/2049 (0%) | 1/2062 (0%) | ||
| Hepatic function abnormal | 0/2049 (0%) | 1/2062 (0%) | ||
| Hepatic steatosis | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Liver disorder | 0/2049 (0%) | 1/2062 (0%) | ||
| Immune system disorders | ||||
| Anaphylactic shock | 1/2049 (0%) | 0/2062 (0%) | ||
| Drug hypersensitivity | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Hypersensitivity | 1/2049 (0%) | 0/2062 (0%) | ||
| Sarcoidosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Infections and infestations | ||||
| Abdominal abscess | 1/2049 (0%) | 0/2062 (0%) | ||
| Abscess | 0/2049 (0%) | 1/2062 (0%) | ||
| Abscess limb | 1/2049 (0%) | 0/2062 (0%) | ||
| Abscess neck | 1/2049 (0%) | 0/2062 (0%) | ||
| Abscess soft tissue | 0/2049 (0%) | 1/2062 (0%) | ||
| Anal abscess | 1/2049 (0%) | 0/2062 (0%) | ||
| Appendicitis | 1/2049 (0%) | 5/2062 (0.2%) | ||
| Appendicitis perforated | 1/2049 (0%) | 0/2062 (0%) | ||
| Arthritis bacterial | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Arthritis infective | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Breast abscess | 1/2049 (0%) | 1/2062 (0%) | ||
| Breast cellulitis | 6/2049 (0.3%) | 4/2062 (0.2%) | ||
| Bronchitis | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Bronchopneumonia | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Cellulitis | 8/2049 (0.4%) | 9/2062 (0.4%) | ||
| Clostridium difficile colitis | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Cystitis | 2/2049 (0.1%) | 3/2062 (0.1%) | ||
| Device related infection | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Diverticulitis | 1/2049 (0%) | 7/2062 (0.3%) | ||
| Encephalitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Endocarditis | 0/2049 (0%) | 1/2062 (0%) | ||
| Erysipelas | 5/2049 (0.2%) | 8/2062 (0.4%) | ||
| Escherichia sepsis | 1/2049 (0%) | 0/2062 (0%) | ||
| Gallbladder empyema | 0/2049 (0%) | 1/2062 (0%) | ||
| Gangrene | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastroenteritis | 7/2049 (0.3%) | 2/2062 (0.1%) | ||
| Gastroenteritis Escherichia coli | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastroenteritis norovirus | 1/2049 (0%) | 1/2062 (0%) | ||
| Helicobacter infection | 1/2049 (0%) | 0/2062 (0%) | ||
| Herpes zoster | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Incision site abscess | 0/2049 (0%) | 1/2062 (0%) | ||
| Infected skin ulcer | 1/2049 (0%) | 0/2062 (0%) | ||
| Infection | 1/2049 (0%) | 3/2062 (0.1%) | ||
| Influenza | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Laryngitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Lobar pneumonia | 0/2049 (0%) | 1/2062 (0%) | ||
| Localised infection | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Lower respiratory tract infection | 2/2049 (0.1%) | 4/2062 (0.2%) | ||
| Lymphangitis | 1/2049 (0%) | 0/2062 (0%) | ||
| Mastitis | 2/2049 (0.1%) | 5/2062 (0.2%) | ||
| Meningitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Nosocomial infection | 0/2049 (0%) | 1/2062 (0%) | ||
| Oral candidiasis | 0/2049 (0%) | 1/2062 (0%) | ||
| Osteomyelitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Otitis media | 1/2049 (0%) | 0/2062 (0%) | ||
| Periorbital cellulitis | 1/2049 (0%) | 0/2062 (0%) | ||
| Peritonitis | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Pharyngeal abscess | 1/2049 (0%) | 0/2062 (0%) | ||
| Pilonidal cyst | 1/2049 (0%) | 0/2062 (0%) | ||
| Pneumonia | 16/2049 (0.8%) | 29/2062 (1.4%) | ||
| Pneumonia klebsiella | 0/2049 (0%) | 1/2062 (0%) | ||
| Pneumonia legionella | 0/2049 (0%) | 1/2062 (0%) | ||
| Post procedural cellulitis | 1/2049 (0%) | 0/2062 (0%) | ||
| Post procedural pneumonia | 1/2049 (0%) | 0/2062 (0%) | ||
| Postoperative wound infection | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Pseudomembranous colitis | 1/2049 (0%) | 1/2062 (0%) | ||
| Pseudomonas bronchitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Pyelonephritis | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Pyelonephritis acute | 1/2049 (0%) | 0/2062 (0%) | ||
| Pyometra | 1/2049 (0%) | 0/2062 (0%) | ||
| Respiratory tract infection | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Sepsis | 3/2049 (0.1%) | 8/2062 (0.4%) | ||
| Septic shock | 0/2049 (0%) | 1/2062 (0%) | ||
| Skin infection | 1/2049 (0%) | 3/2062 (0.1%) | ||
| Soft tissue infection | 0/2049 (0%) | 1/2062 (0%) | ||
| Staphylococcal infection | 1/2049 (0%) | 0/2062 (0%) | ||
| Staphylococcal sepsis | 0/2049 (0%) | 1/2062 (0%) | ||
| Upper respiratory tract infection | 0/2049 (0%) | 1/2062 (0%) | ||
| Urinary tract infection | 7/2049 (0.3%) | 8/2062 (0.4%) | ||
| Urosepsis | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Vaginal infection | 1/2049 (0%) | 0/2062 (0%) | ||
| Vestibular neuronitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Viral diarrhoea | 1/2049 (0%) | 0/2062 (0%) | ||
| Viral infection | 1/2049 (0%) | 0/2062 (0%) | ||
| Vulvitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Wound infection | 3/2049 (0.1%) | 1/2062 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Acetabulum fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Alcohol poisoning | 0/2049 (0%) | 1/2062 (0%) | ||
| Ankle fracture | 14/2049 (0.7%) | 10/2062 (0.5%) | ||
| Arthropod bite | 0/2049 (0%) | 1/2062 (0%) | ||
| Brain contusion | 0/2049 (0%) | 1/2062 (0%) | ||
| Cervical vertebral fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Clavicle fracture | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Compression fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Concussion | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Contusion | 1/2049 (0%) | 0/2062 (0%) | ||
| Dislocation of vertebra | 1/2049 (0%) | 0/2062 (0%) | ||
| Excoriation | 0/2049 (0%) | 1/2062 (0%) | ||
| Face injury | 0/2049 (0%) | 1/2062 (0%) | ||
| Facial bones fracture | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Fall | 17/2049 (0.8%) | 13/2062 (0.6%) | ||
| Femoral neck fracture | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Femur fracture | 8/2049 (0.4%) | 2/2062 (0.1%) | ||
| Fibula fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Foot fracture | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Forearm fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Hand fracture | 1/2049 (0%) | 0/2062 (0%) | ||
| Head injury | 1/2049 (0%) | 1/2062 (0%) | ||
| Hip fracture | 5/2049 (0.2%) | 4/2062 (0.2%) | ||
| Humerus fracture | 9/2049 (0.4%) | 6/2062 (0.3%) | ||
| Incisional hernia | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Joint dislocation | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Joint injury | 1/2049 (0%) | 1/2062 (0%) | ||
| Laceration | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Ligament rupture | 1/2049 (0%) | 0/2062 (0%) | ||
| Ligament sprain | 0/2049 (0%) | 1/2062 (0%) | ||
| Lower limb fracture | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Lumbar vertebral fracture | 4/2049 (0.2%) | 4/2062 (0.2%) | ||
| Meniscus injury | 2/2049 (0.1%) | 4/2062 (0.2%) | ||
| Multiple fractures | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Muscle rupture | 0/2049 (0%) | 1/2062 (0%) | ||
| Muscle strain | 0/2049 (0%) | 1/2062 (0%) | ||
| Overdose | 1/2049 (0%) | 3/2062 (0.1%) | ||
| Patella fracture | 1/2049 (0%) | 1/2062 (0%) | ||
| Pelvic fracture | 3/2049 (0.1%) | 0/2062 (0%) | ||
| Pneumothorax traumatic | 1/2049 (0%) | 0/2062 (0%) | ||
| Post procedural complication | 1/2049 (0%) | 0/2062 (0%) | ||
| Post procedural haemorrhage | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Post procedural hypothyroidism | 1/2049 (0%) | 0/2062 (0%) | ||
| Postoperative hernia | 1/2049 (0%) | 0/2062 (0%) | ||
| Postoperative wound complication | 0/2049 (0%) | 1/2062 (0%) | ||
| Procedural pain | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Pubis fracture | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Pulmonary contusion | 0/2049 (0%) | 1/2062 (0%) | ||
| Radiation pericarditis | 1/2049 (0%) | 0/2062 (0%) | ||
| Radiation pneumonitis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Radiation skin injury | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Radius fracture | 2/2049 (0.1%) | 7/2062 (0.3%) | ||
| Rib fracture | 3/2049 (0.1%) | 1/2062 (0%) | ||
| Road traffic accident | 0/2049 (0%) | 1/2062 (0%) | ||
| Seroma | 0/2049 (0%) | 4/2062 (0.2%) | ||
| Skull fracture | 1/2049 (0%) | 1/2062 (0%) | ||
| Soft tissue injury | 0/2049 (0%) | 1/2062 (0%) | ||
| Spinal compression fracture | 6/2049 (0.3%) | 2/2062 (0.1%) | ||
| Spinal fracture | 1/2049 (0%) | 1/2062 (0%) | ||
| Splenic rupture | 0/2049 (0%) | 1/2062 (0%) | ||
| Sternal fracture | 1/2049 (0%) | 0/2062 (0%) | ||
| Subdural haematoma | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Subdural haemorrhage | 1/2049 (0%) | 0/2062 (0%) | ||
| Tendon rupture | 0/2049 (0%) | 1/2062 (0%) | ||
| Thermal burn | 1/2049 (0%) | 0/2062 (0%) | ||
| Thoracic vertebral fracture | 0/2049 (0%) | 1/2062 (0%) | ||
| Tibia fracture | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Toxicity to various agents | 3/2049 (0.1%) | 0/2062 (0%) | ||
| Tracheal injury | 1/2049 (0%) | 0/2062 (0%) | ||
| Ulna fracture | 1/2049 (0%) | 1/2062 (0%) | ||
| Upper limb fracture | 3/2049 (0.1%) | 5/2062 (0.2%) | ||
| Vascular pseudoaneurysm | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Wrist fracture | 6/2049 (0.3%) | 3/2062 (0.1%) | ||
| Investigations | ||||
| Amylase increased | 0/2049 (0%) | 1/2062 (0%) | ||
| Aspiration pleural cavity | 1/2049 (0%) | 0/2062 (0%) | ||
| Biopsy breast | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Biopsy lymph gland | 1/2049 (0%) | 0/2062 (0%) | ||
| Bone density decreased | 1/2049 (0%) | 0/2062 (0%) | ||
| Carbohydrate antigen 15-3 increased | 0/2049 (0%) | 1/2062 (0%) | ||
| Clostridium test positive | 1/2049 (0%) | 0/2062 (0%) | ||
| Fibrin D dimer increased | 1/2049 (0%) | 0/2062 (0%) | ||
| Haemoglobin decreased | 0/2049 (0%) | 1/2062 (0%) | ||
| International normalised ratio increased | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Lipase increased | 0/2049 (0%) | 1/2062 (0%) | ||
| Mammogram abnormal | 1/2049 (0%) | 0/2062 (0%) | ||
| Mediastinal biopsy | 0/2049 (0%) | 1/2062 (0%) | ||
| Weight decreased | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Weight increased | 1/2049 (0%) | 0/2062 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/2049 (0%) | 1/2062 (0%) | ||
| Dehydration | 7/2049 (0.3%) | 1/2062 (0%) | ||
| Diabetes mellitus | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Fluid overload | 0/2049 (0%) | 1/2062 (0%) | ||
| Hypercalcaemia | 4/2049 (0.2%) | 2/2062 (0.1%) | ||
| Hyperglycaemia | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Hypokalaemia | 0/2049 (0%) | 1/2062 (0%) | ||
| Hyponatraemia | 4/2049 (0.2%) | 0/2062 (0%) | ||
| Hypophagia | 0/2049 (0%) | 1/2062 (0%) | ||
| Hypovolaemia | 1/2049 (0%) | 1/2062 (0%) | ||
| Obesity | 1/2049 (0%) | 0/2062 (0%) | ||
| Type 2 diabetes mellitus | 0/2049 (0%) | 1/2062 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 9/2049 (0.4%) | 6/2062 (0.3%) | ||
| Arthritis | 0/2049 (0%) | 9/2062 (0.4%) | ||
| Back pain | 6/2049 (0.3%) | 10/2062 (0.5%) | ||
| Bone pain | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Compartment syndrome | 0/2049 (0%) | 1/2062 (0%) | ||
| Costochondritis | 1/2049 (0%) | 1/2062 (0%) | ||
| Foot deformity | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Intervertebral disc protrusion | 1/2049 (0%) | 6/2062 (0.3%) | ||
| Joint instability | 1/2049 (0%) | 0/2062 (0%) | ||
| Joint stiffness | 1/2049 (0%) | 0/2062 (0%) | ||
| Kyphosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Loose body in joint | 1/2049 (0%) | 0/2062 (0%) | ||
| Lumbar spinal stenosis | 1/2049 (0%) | 1/2062 (0%) | ||
| Muscle atrophy | 1/2049 (0%) | 0/2062 (0%) | ||
| Muscle spasms | 1/2049 (0%) | 0/2062 (0%) | ||
| Muscular weakness | 1/2049 (0%) | 1/2062 (0%) | ||
| Musculoskeletal chest pain | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Musculoskeletal pain | 2/2049 (0.1%) | 3/2062 (0.1%) | ||
| Musculoskeletal stiffness | 0/2049 (0%) | 1/2062 (0%) | ||
| Myalgia | 1/2049 (0%) | 1/2062 (0%) | ||
| Myopathy | 0/2049 (0%) | 1/2062 (0%) | ||
| Osteoarthritis | 21/2049 (1%) | 15/2062 (0.7%) | ||
| Osteonecrosis | 0/2049 (0%) | 1/2062 (0%) | ||
| Osteopenia | 1/2049 (0%) | 1/2062 (0%) | ||
| Osteoporosis | 3/2049 (0.1%) | 1/2062 (0%) | ||
| Pain in extremity | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Polyarthritis | 1/2049 (0%) | 0/2062 (0%) | ||
| Pseudarthrosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Rheumatoid arthritis | 1/2049 (0%) | 0/2062 (0%) | ||
| Rotator cuff syndrome | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Spinal column stenosis | 4/2049 (0.2%) | 1/2062 (0%) | ||
| Spinal osteoarthritis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Spinal pain | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Spondylolisthesis | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Synovial cyst | 0/2049 (0%) | 1/2062 (0%) | ||
| Synovitis | 1/2049 (0%) | 0/2062 (0%) | ||
| Tenosynovitis | 0/2049 (0%) | 1/2062 (0%) | ||
| Trigger finger | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma of colon | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Adenocarcinoma of the cervix | 0/2049 (0%) | 1/2062 (0%) | ||
| Angiomyolipoma | 1/2049 (0%) | 0/2062 (0%) | ||
| B-cell lymphoma | 1/2049 (0%) | 0/2062 (0%) | ||
| Basal cell carcinoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Benign laryngeal neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Benign lymph node neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Benign neoplasm | 1/2049 (0%) | 0/2062 (0%) | ||
| Benign neoplasm of thyroid gland | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Benign salivary gland neoplasm | 1/2049 (0%) | 0/2062 (0%) | ||
| Bladder cancer | 1/2049 (0%) | 0/2062 (0%) | ||
| Bone cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Brain neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Breast cancer | 1/2049 (0%) | 1/2062 (0%) | ||
| Colon cancer | 1/2049 (0%) | 1/2062 (0%) | ||
| Colon neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Diffuse large B-cell lymphoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Fibroma | 1/2049 (0%) | 1/2062 (0%) | ||
| Fibromatosis | 0/2049 (0%) | 1/2062 (0%) | ||
| Gallbladder cancer | 1/2049 (0%) | 0/2062 (0%) | ||
| Gastric cancer | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Gastrointestinal carcinoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Gastrointestinal tract adenoma | 1/2049 (0%) | 0/2062 (0%) | ||
| Glioblastoma multiforme | 1/2049 (0%) | 0/2062 (0%) | ||
| Haemangioma | 1/2049 (0%) | 0/2062 (0%) | ||
| Hepatic cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Lip and/or oral cavity cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Lip neoplasm benign | 1/2049 (0%) | 0/2062 (0%) | ||
| Lung neoplasm malignant | 1/2049 (0%) | 1/2062 (0%) | ||
| Lymphangiosis carcinomatosa | 0/2049 (0%) | 1/2062 (0%) | ||
| Malignant melanoma in situ | 1/2049 (0%) | 0/2062 (0%) | ||
| Malignant neoplasm progression | 1/2049 (0%) | 1/2062 (0%) | ||
| Malignant peritoneal neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Malignant pleural effusion | 0/2049 (0%) | 1/2062 (0%) | ||
| Meningioma | 1/2049 (0%) | 1/2062 (0%) | ||
| Metastases to abdominal cavity | 0/2049 (0%) | 1/2062 (0%) | ||
| Metastases to bone | 1/2049 (0%) | 1/2062 (0%) | ||
| Metastases to central nervous system | 1/2049 (0%) | 0/2062 (0%) | ||
| Metastases to liver | 1/2049 (0%) | 0/2062 (0%) | ||
| Metastases to peritoneum | 1/2049 (0%) | 0/2062 (0%) | ||
| Metastatic pain | 0/2049 (0%) | 1/2062 (0%) | ||
| Neurilemmoma benign | 1/2049 (0%) | 0/2062 (0%) | ||
| Non-small cell lung cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Ovarian cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Ovarian cancer stage III | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Ovarian fibroma | 0/2049 (0%) | 1/2062 (0%) | ||
| Ovarian neoplasm | 1/2049 (0%) | 0/2062 (0%) | ||
| Pancreatic carcinoma | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Pituitary tumour benign | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Pleomorphic adenoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Rectal adenoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Rectosigmoid cancer | 0/2049 (0%) | 1/2062 (0%) | ||
| Retro-orbital neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Salivary gland neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Schwannoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Seborrhoeic keratosis | 0/2049 (0%) | 1/2062 (0%) | ||
| Signet-ring cell carcinoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Squamous cell carcinoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Squamous cell carcinoma of skin | 1/2049 (0%) | 4/2062 (0.2%) | ||
| Superficial spreading melanoma stage unspecified | 0/2049 (0%) | 1/2062 (0%) | ||
| Thyroid adenoma | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Thyroid neoplasm | 0/2049 (0%) | 1/2062 (0%) | ||
| Uterine leiomyoma | 3/2049 (0.1%) | 1/2062 (0%) | ||
| Waldenstrom's macroglobulinaemia | 1/2049 (0%) | 0/2062 (0%) | ||
| Nervous system disorders | ||||
| Amnesia | 1/2049 (0%) | 1/2062 (0%) | ||
| Ataxia | 1/2049 (0%) | 0/2062 (0%) | ||
| Balance disorder | 1/2049 (0%) | 0/2062 (0%) | ||
| Carotid artery stenosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Carpal tunnel syndrome | 2/2049 (0.1%) | 6/2062 (0.3%) | ||
| Cerebral amyloid angiopathy | 1/2049 (0%) | 0/2062 (0%) | ||
| Cerebral haemorrhage | 0/2049 (0%) | 1/2062 (0%) | ||
| Cerebral infarction | 1/2049 (0%) | 6/2062 (0.3%) | ||
| Cerebral ischaemia | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Cerebrovascular accident | 8/2049 (0.4%) | 5/2062 (0.2%) | ||
| Cervicobrachial syndrome | 1/2049 (0%) | 0/2062 (0%) | ||
| Convulsion | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Dementia | 1/2049 (0%) | 1/2062 (0%) | ||
| Dementia Alzheimer's type | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Dizziness | 3/2049 (0.1%) | 6/2062 (0.3%) | ||
| Dysarthria | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Encephalopathy | 1/2049 (0%) | 1/2062 (0%) | ||
| Epilepsy | 0/2049 (0%) | 1/2062 (0%) | ||
| Facial paresis | 1/2049 (0%) | 0/2062 (0%) | ||
| Haemorrhage intracranial | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Headache | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Hepatic encephalopathy | 1/2049 (0%) | 0/2062 (0%) | ||
| Horner's syndrome | 1/2049 (0%) | 0/2062 (0%) | ||
| Hypoaesthesia | 1/2049 (0%) | 1/2062 (0%) | ||
| Hypogeusia | 1/2049 (0%) | 0/2062 (0%) | ||
| Intracranial aneurysm | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Ischaemic stroke | 1/2049 (0%) | 0/2062 (0%) | ||
| Lumbar radiculopathy | 1/2049 (0%) | 0/2062 (0%) | ||
| Monoplegia | 1/2049 (0%) | 0/2062 (0%) | ||
| Multiple sclerosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Multiple sclerosis relapse | 1/2049 (0%) | 0/2062 (0%) | ||
| Myasthenia gravis | 1/2049 (0%) | 0/2062 (0%) | ||
| Optic neuritis | 1/2049 (0%) | 0/2062 (0%) | ||
| Parkinsonism | 0/2049 (0%) | 1/2062 (0%) | ||
| Partial seizures | 1/2049 (0%) | 0/2062 (0%) | ||
| Petit mal epilepsy | 1/2049 (0%) | 0/2062 (0%) | ||
| Presyncope | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Sciatica | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Sensory loss | 0/2049 (0%) | 1/2062 (0%) | ||
| Speech disorder | 0/2049 (0%) | 1/2062 (0%) | ||
| Spinal claudication | 1/2049 (0%) | 0/2062 (0%) | ||
| Spinal epidural haemorrhage | 1/2049 (0%) | 0/2062 (0%) | ||
| Subarachnoid haemorrhage | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Syncope | 13/2049 (0.6%) | 4/2062 (0.2%) | ||
| Tardive dyskinesia | 0/2049 (0%) | 1/2062 (0%) | ||
| Transient global amnesia | 1/2049 (0%) | 1/2062 (0%) | ||
| Transient ischaemic attack | 8/2049 (0.4%) | 5/2062 (0.2%) | ||
| Tremor | 1/2049 (0%) | 0/2062 (0%) | ||
| Trigeminal neuralgia | 0/2049 (0%) | 1/2062 (0%) | ||
| VIIth nerve paralysis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Vertebrobasilar insufficiency | 0/2049 (0%) | 1/2062 (0%) | ||
| Psychiatric disorders | ||||
| Abnormal behaviour | 0/2049 (0%) | 1/2062 (0%) | ||
| Agitation | 0/2049 (0%) | 1/2062 (0%) | ||
| Anxiety | 0/2049 (0%) | 1/2062 (0%) | ||
| Completed suicide | 0/2049 (0%) | 1/2062 (0%) | ||
| Confusional state | 2/2049 (0.1%) | 8/2062 (0.4%) | ||
| Delirium | 1/2049 (0%) | 0/2062 (0%) | ||
| Depressed mood | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Depression | 9/2049 (0.4%) | 11/2062 (0.5%) | ||
| Drug dependence | 1/2049 (0%) | 0/2062 (0%) | ||
| Intentional self-injury | 0/2049 (0%) | 1/2062 (0%) | ||
| Major depression | 1/2049 (0%) | 1/2062 (0%) | ||
| Mental disorder | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Mental status changes | 3/2049 (0.1%) | 2/2062 (0.1%) | ||
| Mood disorder due to a general medical condition | 0/2049 (0%) | 1/2062 (0%) | ||
| Mood swings | 1/2049 (0%) | 0/2062 (0%) | ||
| Somatisation disorder | 0/2049 (0%) | 1/2062 (0%) | ||
| Suicide attempt | 1/2049 (0%) | 1/2062 (0%) | ||
| Renal and urinary disorders | ||||
| Calculus bladder | 1/2049 (0%) | 0/2062 (0%) | ||
| Calculus ureteric | 0/2049 (0%) | 1/2062 (0%) | ||
| Calculus urinary | 1/2049 (0%) | 1/2062 (0%) | ||
| Haematuria | 0/2049 (0%) | 3/2062 (0.1%) | ||
| Hydronephrosis | 1/2049 (0%) | 1/2062 (0%) | ||
| Hypertonic bladder | 0/2049 (0%) | 1/2062 (0%) | ||
| Nephrolithiasis | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Nephrotic syndrome | 0/2049 (0%) | 1/2062 (0%) | ||
| Polyuria | 0/2049 (0%) | 1/2062 (0%) | ||
| Renal colic | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Renal failure | 1/2049 (0%) | 7/2062 (0.3%) | ||
| Renal failure acute | 6/2049 (0.3%) | 2/2062 (0.1%) | ||
| Renal failure chronic | 0/2049 (0%) | 1/2062 (0%) | ||
| Renal impairment | 1/2049 (0%) | 0/2062 (0%) | ||
| Stress urinary incontinence | 1/2049 (0%) | 0/2062 (0%) | ||
| Urethral caruncle | 0/2049 (0%) | 1/2062 (0%) | ||
| Urethral obstruction | 1/2049 (0%) | 0/2062 (0%) | ||
| Urinary incontinence | 0/2049 (0%) | 4/2062 (0.2%) | ||
| Urinary tract obstruction | 0/2049 (0%) | 1/2062 (0%) | ||
| Reproductive system and breast disorders | ||||
| Adnexa uteri mass | 0/2049 (0%) | 1/2062 (0%) | ||
| Anisomastia | 0/2049 (0%) | 1/2062 (0%) | ||
| Breast calcifications | 1/2049 (0%) | 0/2062 (0%) | ||
| Breast fibrosis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Breast haematoma | 1/2049 (0%) | 1/2062 (0%) | ||
| Breast inflammation | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Breast mass | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Breast oedema | 1/2049 (0%) | 0/2062 (0%) | ||
| Colpocele | 0/2049 (0%) | 1/2062 (0%) | ||
| Cystocele | 1/2049 (0%) | 1/2062 (0%) | ||
| Endometrial hyperplasia | 1/2049 (0%) | 0/2062 (0%) | ||
| Female genital tract fistula | 1/2049 (0%) | 1/2062 (0%) | ||
| Genital prolapse | 1/2049 (0%) | 0/2062 (0%) | ||
| Metrorrhagia | 1/2049 (0%) | 0/2062 (0%) | ||
| Nipple disorder | 0/2049 (0%) | 1/2062 (0%) | ||
| Nipple exudate bloody | 0/2049 (0%) | 1/2062 (0%) | ||
| Ovarian cyst | 5/2049 (0.2%) | 3/2062 (0.1%) | ||
| Pelvic prolapse | 1/2049 (0%) | 0/2062 (0%) | ||
| Perineal pain | 1/2049 (0%) | 0/2062 (0%) | ||
| Rectocele | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Uterine fistula | 0/2049 (0%) | 1/2062 (0%) | ||
| Uterine polyp | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Uterine prolapse | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Vaginal haemorrhage | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Vaginal inflammation | 1/2049 (0%) | 0/2062 (0%) | ||
| Vaginal prolapse | 1/2049 (0%) | 0/2062 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/2049 (0%) | 0/2062 (0%) | ||
| Acute respiratory failure | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Aspiration | 1/2049 (0%) | 0/2062 (0%) | ||
| Asthma | 1/2049 (0%) | 3/2062 (0.1%) | ||
| Bronchial hyperreactivity | 0/2049 (0%) | 1/2062 (0%) | ||
| Bronchospasm | 1/2049 (0%) | 0/2062 (0%) | ||
| Choking | 1/2049 (0%) | 0/2062 (0%) | ||
| Chronic obstructive pulmonary disease | 6/2049 (0.3%) | 9/2062 (0.4%) | ||
| Dyspnoea | 10/2049 (0.5%) | 7/2062 (0.3%) | ||
| Dyspnoea exertional | 1/2049 (0%) | 0/2062 (0%) | ||
| Emphysema | 1/2049 (0%) | 1/2062 (0%) | ||
| Epistaxis | 1/2049 (0%) | 0/2062 (0%) | ||
| Haemoptysis | 1/2049 (0%) | 2/2062 (0.1%) | ||
| Hypercapnia | 0/2049 (0%) | 1/2062 (0%) | ||
| Hypoxia | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Idiopathic pulmonary fibrosis | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Pleural effusion | 5/2049 (0.2%) | 3/2062 (0.1%) | ||
| Pleuritic pain | 0/2049 (0%) | 1/2062 (0%) | ||
| Pneumonia aspiration | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Pneumothorax | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Productive cough | 1/2049 (0%) | 0/2062 (0%) | ||
| Pulmonary embolism | 6/2049 (0.3%) | 12/2062 (0.6%) | ||
| Pulmonary fibrosis | 1/2049 (0%) | 1/2062 (0%) | ||
| Pulmonary hypertension | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Pulmonary oedema | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Respiratory distress | 1/2049 (0%) | 0/2062 (0%) | ||
| Respiratory failure | 3/2049 (0.1%) | 3/2062 (0.1%) | ||
| Sinus congestion | 1/2049 (0%) | 0/2062 (0%) | ||
| Sleep apnoea syndrome | 0/2049 (0%) | 1/2062 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/2049 (0%) | 0/2062 (0%) | ||
| Dermal cyst | 0/2049 (0%) | 1/2062 (0%) | ||
| Erythema multiforme | 2/2049 (0.1%) | 0/2062 (0%) | ||
| Erythrodermic psoriasis | 0/2049 (0%) | 1/2062 (0%) | ||
| Hypertrophic scar | 0/2049 (0%) | 1/2062 (0%) | ||
| Keloid scar | 0/2049 (0%) | 1/2062 (0%) | ||
| Pruritus | 1/2049 (0%) | 0/2062 (0%) | ||
| Rash maculo-papular | 1/2049 (0%) | 0/2062 (0%) | ||
| Skin lesion | 0/2049 (0%) | 1/2062 (0%) | ||
| Skin necrosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Urticaria | 0/2049 (0%) | 1/2062 (0%) | ||
| Urticaria chronic | 0/2049 (0%) | 1/2062 (0%) | ||
| Surgical and medical procedures | ||||
| Breast lump removal | 1/2049 (0%) | 0/2062 (0%) | ||
| Breast operation | 1/2049 (0%) | 0/2062 (0%) | ||
| Breast prosthesis implantation | 5/2049 (0.2%) | 10/2062 (0.5%) | ||
| Breast prosthesis removal | 1/2049 (0%) | 1/2062 (0%) | ||
| Breast reconstruction | 24/2049 (1.2%) | 16/2062 (0.8%) | ||
| Central venous catheter removal | 0/2049 (0%) | 1/2062 (0%) | ||
| Knee arthroplasty | 1/2049 (0%) | 0/2062 (0%) | ||
| Mammoplasty | 6/2049 (0.3%) | 3/2062 (0.1%) | ||
| Mastectomy | 5/2049 (0.2%) | 6/2062 (0.3%) | ||
| Mechanical ventilation | 0/2049 (0%) | 1/2062 (0%) | ||
| Medical device removal | 1/2049 (0%) | 0/2062 (0%) | ||
| Meniscus removal | 1/2049 (0%) | 0/2062 (0%) | ||
| Modified radical mastectomy | 1/2049 (0%) | 0/2062 (0%) | ||
| Removal of internal fixation | 1/2049 (0%) | 0/2062 (0%) | ||
| Scar excision | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Spinal laminectomy | 0/2049 (0%) | 1/2062 (0%) | ||
| Wound treatment | 1/2049 (0%) | 0/2062 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Aortic aneurysm rupture | 1/2049 (0%) | 0/2062 (0%) | ||
| Aortic dissection | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Aortic stenosis | 2/2049 (0.1%) | 1/2062 (0%) | ||
| Aortic thrombosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Arterial disorder | 1/2049 (0%) | 0/2062 (0%) | ||
| Arterial occlusive disease | 1/2049 (0%) | 0/2062 (0%) | ||
| Arteriosclerosis | 0/2049 (0%) | 1/2062 (0%) | ||
| Capillary fragility | 1/2049 (0%) | 0/2062 (0%) | ||
| Circulatory collapse | 3/2049 (0.1%) | 4/2062 (0.2%) | ||
| Deep vein thrombosis | 2/2049 (0.1%) | 8/2062 (0.4%) | ||
| Embolism | 0/2049 (0%) | 1/2062 (0%) | ||
| Extremity necrosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Femoral artery occlusion | 1/2049 (0%) | 0/2062 (0%) | ||
| Haematoma | 2/2049 (0.1%) | 2/2062 (0.1%) | ||
| Haemorrhage | 1/2049 (0%) | 0/2062 (0%) | ||
| Hypertension | 7/2049 (0.3%) | 4/2062 (0.2%) | ||
| Hypertensive crisis | 4/2049 (0.2%) | 0/2062 (0%) | ||
| Hypotension | 3/2049 (0.1%) | 1/2062 (0%) | ||
| Hypovolaemic shock | 0/2049 (0%) | 1/2062 (0%) | ||
| Iliac artery occlusion | 1/2049 (0%) | 1/2062 (0%) | ||
| Intra-abdominal haematoma | 0/2049 (0%) | 1/2062 (0%) | ||
| Lymphocele | 0/2049 (0%) | 1/2062 (0%) | ||
| Lymphoedema | 2/2049 (0.1%) | 3/2062 (0.1%) | ||
| Orthostatic hypotension | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Peripheral arterial occlusive disease | 0/2049 (0%) | 1/2062 (0%) | ||
| Peripheral artery stenosis | 0/2049 (0%) | 1/2062 (0%) | ||
| Peripheral ischaemia | 1/2049 (0%) | 1/2062 (0%) | ||
| Peripheral vascular disorder | 1/2049 (0%) | 0/2062 (0%) | ||
| Peripheral venous disease | 0/2049 (0%) | 1/2062 (0%) | ||
| Temporal arteritis | 0/2049 (0%) | 1/2062 (0%) | ||
| Thromboangiitis obliterans | 1/2049 (0%) | 0/2062 (0%) | ||
| Thrombosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Varicose vein | 0/2049 (0%) | 2/2062 (0.1%) | ||
| Vena cava thrombosis | 1/2049 (0%) | 0/2062 (0%) | ||
| Venous thrombosis limb | 1/2049 (0%) | 0/2062 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Letrozole | Anastrozole | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1747/2049 (85.3%) | 1762/2062 (85.5%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 127/2049 (6.2%) | 148/2062 (7.2%) | ||
| General disorders | ||||
| Fatigue | 345/2049 (16.8%) | 341/2062 (16.5%) | ||
| Oedema peripheral | 100/2049 (4.9%) | 104/2062 (5%) | ||
| Injury, poisoning and procedural complications | ||||
| Radiation skin injury | 120/2049 (5.9%) | 88/2062 (4.3%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercholesterolaemia | 155/2049 (7.6%) | 151/2062 (7.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 983/2049 (48%) | 983/2062 (47.7%) | ||
| Back pain | 207/2049 (10.1%) | 187/2062 (9.1%) | ||
| Bone pain | 138/2049 (6.7%) | 120/2062 (5.8%) | ||
| Musculoskeletal pain | 122/2049 (6%) | 144/2062 (7%) | ||
| Myalgia | 232/2049 (11.3%) | 211/2062 (10.2%) | ||
| Osteopenia | 202/2049 (9.9%) | 172/2062 (8.3%) | ||
| Osteoporosis | 221/2049 (10.8%) | 224/2062 (10.9%) | ||
| Pain in extremity | 167/2049 (8.2%) | 174/2062 (8.4%) | ||
| Nervous system disorders | ||||
| Dizziness | 92/2049 (4.5%) | 107/2062 (5.2%) | ||
| Headache | 127/2049 (6.2%) | 164/2062 (8%) | ||
| Psychiatric disorders | ||||
| Depression | 141/2049 (6.9%) | 129/2062 (6.3%) | ||
| Insomnia | 160/2049 (7.8%) | 149/2062 (7.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 106/2049 (5.2%) | 120/2062 (5.8%) | ||
| Dyspnoea | 111/2049 (5.4%) | 92/2062 (4.5%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 126/2049 (6.1%) | 134/2062 (6.5%) | ||
| Vascular disorders | ||||
| Hot flush | 666/2049 (32.5%) | 666/2062 (32.3%) | ||
| Hypertension | 152/2049 (7.4%) | 145/2062 (7%) | ||
| Lymphoedema | 158/2049 (7.7%) | 177/2062 (8.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00248170
Other Study ID Numbers:
- CFEM345D2411
- 2005-004263-35
- EUDRACT number 2005-004263-35
First Posted:
Nov 3, 2005
Last Update Posted:
Apr 19, 2016
Last Verified:
Mar 1, 2016