Trial Outcomes & Findings for Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer (NCT NCT00248170)
NCT ID: NCT00248170
Last Updated: 2016-04-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4172 participants
Primary outcome timeframe
84 months
Results posted on
2016-04-19
Participant Flow
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.
Participant milestones
| Measure |
Letrozole
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
1 mg p.o. once daily
|
|---|---|---|
|
Overall Study
STARTED
|
2078
|
2094
|
|
Overall Study
Safety Set
|
2049
|
2062
|
|
Overall Study
COMPLETED
|
1317
|
1286
|
|
Overall Study
NOT COMPLETED
|
761
|
808
|
|
Overall Study
Intent-to-treat (ITT)
|
2061
|
2075
|
Reasons for withdrawal
| Measure |
Letrozole
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
1 mg p.o. once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
71
|
79
|
|
Overall Study
Protocol Violation
|
35
|
30
|
|
Overall Study
Lost to Follow-up
|
28
|
35
|
|
Overall Study
Disease progression
|
196
|
216
|
|
Overall Study
Death
|
28
|
47
|
|
Overall Study
Adverse Event
|
311
|
296
|
|
Overall Study
Administrative problems
|
22
|
25
|
|
Overall Study
Abnormal test procedure(s) result
|
49
|
61
|
|
Overall Study
Abnormal laboratory values
|
4
|
0
|
|
Overall Study
Protocol deviation
|
17
|
19
|
Baseline Characteristics
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
Total
n=4136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 8.45 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
2061 Participants
n=5 Participants
|
2075 Participants
n=7 Participants
|
4136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 84 monthsPopulation: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
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.
Outcome measures
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Disease Free Survival
|
NA Months
Interval 84.14 to
The median was not reached and therefore, could not be calculated.
|
NA Months
The median was not reached and therefore, could not be calculated.
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Overall Survival
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
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.
Outcome measures
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Time to Development of Distant Metastases
|
NA Months
Interval 84.14 to
The median was not reached and therefore, the median could not be calculated.
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
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.
Outcome measures
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Time to Development of Contra Lateral Breast Cancer
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
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.
Outcome measures
| Measure |
Letrozole
n=2061 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2075 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Distant Disease-free Survival
|
NA Months
Interval 84.14 to
The median was not reached and therefore, the median could not be calculated.
|
NA Months
The median was not reached and therefore, the median could not be calculated.
|
SECONDARY outcome
Timeframe: baseline, 6, 12, 24, 36, 48 and 60 monthsPopulation: Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.
Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Outcome measures
| Measure |
Letrozole
n=2049 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2062 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Change From Baseline in Serum Lipid Profiles
6 months
|
5.643 mg/dL
Interval 5.584 to 5.701
|
5.553 mg/dL
Interval 5.495 to 5.611
|
|
Change From Baseline in Serum Lipid Profiles
48 months
|
5.395 mg/dL
Interval 5.323 to 5.468
|
5.366 mg/dL
Interval 5.293 to 5.438
|
|
Change From Baseline in Serum Lipid Profiles
60 months
|
5.375 mg/dL
Interval 5.3 to 5.451
|
5.368 mg/dL
Interval 5.292 to 5.443
|
|
Change From Baseline in Serum Lipid Profiles
12 months
|
5.569 mg/dL
Interval 5.51 to 5.629
|
5.511 mg/dL
Interval 5.452 to 5.57
|
|
Change From Baseline in Serum Lipid Profiles
24 months
|
5.508 mg/dL
Interval 5.445 to 5.572
|
5.436 mg/dL
Interval 5.373 to 5.499
|
|
Change From Baseline in Serum Lipid Profiles
36 months
|
5.429 mg/dL
Interval 5.359 to 5.5
|
5.427 mg/dL
Interval 5.357 to 5.497
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.
The incidence of clinical fractures was analyzed.
Outcome measures
| Measure |
Letrozole
n=2049 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2062 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Percentage of Participants Who Experienced Clinical Fracture Events
|
9.3 Percentage of participants
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.
The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Outcome measures
| Measure |
Letrozole
n=2049 Participants
2.5 mg by mouth (p.o.) once daily
|
Anastrozole
n=2062 Participants
1 mg p.o. once daily
|
|---|---|---|
|
Percentage of Participants Who Experienced Cardiovascular Events
Ischemic heart disease
|
2.4 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Who Experienced Cardiovascular Events
Cardiac failures
|
1.5 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Cardiovascular Events
Cerebrovascular accidents
|
1.6 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Who Experienced Cardiovascular Events
Thromboembolic events
|
1.2 Percentage of participants
|
1.2 Percentage of participants
|
Adverse Events
Letrozole
Serious events: 486 serious events
Other events: 1747 other events
Deaths: 0 deaths
Anastrozole
Serious events: 520 serious events
Other events: 1762 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Letrozole
n=2049 participants at risk
Letrozole
|
Anastrozole
n=2062 participants at risk
Anastrozole
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
8/2049
|
0.24%
5/2062
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Gait disturbance
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Gastric polyps
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
3/2049
|
0.24%
5/2062
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Haematochezia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.10%
2/2049
|
0.00%
0/2062
|
|
General disorders
General physical health deterioration
|
0.20%
4/2049
|
0.15%
3/2062
|
|
General disorders
Impaired healing
|
0.05%
1/2049
|
0.05%
1/2062
|
|
General disorders
Implant site extravasation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
General disorders
Injection site phlebitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Malaise
|
0.10%
2/2049
|
0.15%
3/2062
|
|
General disorders
Multi-organ failure
|
0.05%
1/2049
|
0.05%
1/2062
|
|
General disorders
Non-cardiac chest pain
|
0.15%
3/2049
|
0.10%
2/2062
|
|
General disorders
Oedema peripheral
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Pain
|
0.00%
0/2049
|
0.10%
2/2062
|
|
General disorders
Patient-device incompatibility
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Pyrexia
|
0.10%
2/2049
|
0.39%
8/2062
|
|
Gastrointestinal disorders
Ileus
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.15%
3/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.34%
7/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Melaena
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Mouth cyst
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Nausea
|
0.54%
11/2049
|
0.29%
6/2062
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.10%
2/2049
|
0.24%
5/2062
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
2/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Stomatitis
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Vomiting
|
0.54%
11/2049
|
0.29%
6/2062
|
|
General disorders
Asthenia
|
0.00%
0/2049
|
0.29%
6/2062
|
|
General disorders
Cardiac death
|
0.10%
2/2049
|
0.00%
0/2062
|
|
General disorders
Chest discomfort
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Chest pain
|
0.10%
2/2049
|
0.05%
1/2062
|
|
General disorders
Death
|
0.10%
2/2049
|
0.10%
2/2062
|
|
General disorders
Device damage
|
0.05%
1/2049
|
0.00%
0/2062
|
|
General disorders
Device dislocation
|
0.00%
0/2049
|
0.10%
2/2062
|
|
General disorders
Device malfunction
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Disease progression
|
0.10%
2/2049
|
0.10%
2/2062
|
|
General disorders
Disease recurrence
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Drowning
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Fat necrosis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
General disorders
Fatigue
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
4/2049
|
0.15%
3/2062
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Angina pectoris
|
0.39%
8/2049
|
0.39%
8/2062
|
|
Cardiac disorders
Angina unstable
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Arrhythmia
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Atrial fibrillation
|
0.93%
19/2049
|
0.73%
15/2062
|
|
Cardiac disorders
Atrioventricular block complete
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Bradycardia
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Bundle branch block
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
2/2049
|
0.19%
4/2062
|
|
Cardiac disorders
Cardiac disorder
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Cardiac failure
|
0.44%
9/2049
|
0.15%
3/2062
|
|
Cardiac disorders
Cardiac failure acute
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Cardiac failure chronic
|
0.15%
3/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Cardiac failure congestive
|
0.44%
9/2049
|
0.19%
4/2062
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Cardiac tamponade
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Cor pulmonale
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
7/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Gastrocardiac syndrome
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Mitral valve disease
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Mitral valve incompetence
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
5/2049
|
0.19%
4/2062
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Palpitations
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Tachyarrhythmia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Tachycardia
|
0.15%
3/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Congenital, familial and genetic disorders
Syndactyly
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Ear and labyrinth disorders
Tinnitus
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
8/2049
|
0.05%
1/2062
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Endocrine disorders
Goitre
|
0.20%
4/2049
|
0.10%
2/2062
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Endocrine disorders
Hypothyroidism
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Endocrine disorders
Toxic nodular goitre
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Eye disorders
Cataract
|
0.44%
9/2049
|
0.10%
2/2062
|
|
Eye disorders
Dacryostenosis acquired
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Eye disorders
Diplopia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Eye disorders
Glaucoma
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Eye disorders
Lens dislocation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Eye disorders
Macular hole
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Eye disorders
Open angle glaucoma
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Eye disorders
Retinal detachment
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Eye disorders
Retinal vein thrombosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Eye disorders
Vision blurred
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Abdominal distension
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
9/2049
|
0.24%
5/2062
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.05%
1/2049
|
0.15%
3/2062
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
6/2049
|
0.34%
7/2062
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Anal sphincter atony
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Colitis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.05%
1/2049
|
0.00%
0/2062
|
|
General disorders
Sudden death
|
0.00%
0/2049
|
0.05%
1/2062
|
|
General disorders
Thrombosis in device
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
7/2049
|
0.24%
5/2062
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
8/2049
|
0.53%
11/2062
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Immune system disorders
Anaphylactic shock
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Immune system disorders
Drug hypersensitivity
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Immune system disorders
Sarcoidosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Abdominal abscess
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Abscess
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Abscess limb
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Abscess neck
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Anal abscess
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2049
|
0.24%
5/2062
|
|
Infections and infestations
Appendicitis perforated
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Arthritis bacterial
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Infections and infestations
Breast abscess
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Infections and infestations
Breast cellulitis
|
0.29%
6/2049
|
0.19%
4/2062
|
|
Infections and infestations
Bronchitis
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Infections and infestations
Bronchopneumonia
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Infections and infestations
Cellulitis
|
0.39%
8/2049
|
0.44%
9/2062
|
|
Infections and infestations
Clostridium difficile colitis
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Infections and infestations
Cystitis
|
0.10%
2/2049
|
0.15%
3/2062
|
|
Infections and infestations
Device related infection
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/2049
|
0.34%
7/2062
|
|
Infections and infestations
Encephalitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Endocarditis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Erysipelas
|
0.24%
5/2049
|
0.39%
8/2062
|
|
Infections and infestations
Escherichia sepsis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Gangrene
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Gastroenteritis
|
0.34%
7/2049
|
0.10%
2/2062
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Infections and infestations
Helicobacter infection
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Infected skin ulcer
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Infection
|
0.05%
1/2049
|
0.15%
3/2062
|
|
Infections and infestations
Influenza
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Infections and infestations
Laryngitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Localised infection
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
2/2049
|
0.19%
4/2062
|
|
Infections and infestations
Lymphangitis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Mastitis
|
0.10%
2/2049
|
0.24%
5/2062
|
|
Infections and infestations
Meningitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Otitis media
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Periorbital cellulitis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Peritonitis
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Infections and infestations
Pharyngeal abscess
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Pilonidal cyst
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Pneumonia
|
0.78%
16/2049
|
1.4%
29/2062
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Post procedural cellulitis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Post procedural pneumonia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Infections and infestations
Pseudomembranous colitis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Pyelonephritis
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Pyometra
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Infections and infestations
Sepsis
|
0.15%
3/2049
|
0.39%
8/2062
|
|
Infections and infestations
Septic shock
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Skin infection
|
0.05%
1/2049
|
0.15%
3/2062
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Urinary tract infection
|
0.34%
7/2049
|
0.39%
8/2062
|
|
Infections and infestations
Urosepsis
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Infections and infestations
Vaginal infection
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Viral diarrhoea
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Viral infection
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Infections and infestations
Vulvitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Infections and infestations
Wound infection
|
0.15%
3/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.68%
14/2049
|
0.48%
10/2062
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
17/2049
|
0.63%
13/2062
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
8/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
3/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
5/2049
|
0.19%
4/2062
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
9/2049
|
0.29%
6/2062
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Laceration
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.15%
3/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
4/2049
|
0.19%
4/2062
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.10%
2/2049
|
0.19%
4/2062
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Overdose
|
0.05%
1/2049
|
0.15%
3/2062
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.15%
3/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Post procedural hypothyroidism
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Radiation pericarditis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
2/2049
|
0.34%
7/2062
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
3/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/2049
|
0.19%
4/2062
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.29%
6/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
3/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.15%
3/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.15%
3/2049
|
0.24%
5/2062
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.29%
6/2049
|
0.15%
3/2062
|
|
Investigations
Amylase increased
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Investigations
Aspiration pleural cavity
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Biopsy breast
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Investigations
Biopsy lymph gland
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Bone density decreased
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Carbohydrate antigen 15-3 increased
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Investigations
Clostridium test positive
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Fibrin D dimer increased
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Investigations
International normalised ratio increased
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Investigations
Lipase increased
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Investigations
Mammogram abnormal
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Investigations
Mediastinal biopsy
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Investigations
Weight decreased
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Investigations
Weight increased
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
7/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.20%
4/2049
|
0.10%
2/2062
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
4/2049
|
0.00%
0/2062
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Metabolism and nutrition disorders
Obesity
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.44%
9/2049
|
0.29%
6/2062
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2049
|
0.44%
9/2062
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
6/2049
|
0.48%
10/2062
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
1/2049
|
0.29%
6/2062
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.10%
2/2049
|
0.15%
3/2062
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
21/2049
|
0.73%
15/2062
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.15%
3/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.20%
4/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibromatosis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm benign
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage III
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retro-orbital neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Signet-ring cell carcinoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.05%
1/2049
|
0.19%
4/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.15%
3/2049
|
0.05%
1/2062
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Amnesia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Ataxia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Balance disorder
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Carotid artery stenosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.10%
2/2049
|
0.29%
6/2062
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
1/2049
|
0.29%
6/2062
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
8/2049
|
0.24%
5/2062
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Nervous system disorders
Dementia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Dizziness
|
0.15%
3/2049
|
0.29%
6/2062
|
|
Nervous system disorders
Dysarthria
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Nervous system disorders
Encephalopathy
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Facial paresis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Headache
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Horner's syndrome
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Hypoaesthesia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Hypogeusia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Intracranial aneurysm
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Nervous system disorders
Ischaemic stroke
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Monoplegia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Multiple sclerosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Myasthenia gravis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Optic neuritis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Partial seizures
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Petit mal epilepsy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Presyncope
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Sciatica
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Spinal claudication
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Spinal epidural haemorrhage
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Nervous system disorders
Syncope
|
0.63%
13/2049
|
0.19%
4/2062
|
|
Nervous system disorders
Tardive dyskinesia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Transient global amnesia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
8/2049
|
0.24%
5/2062
|
|
Nervous system disorders
Tremor
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Confusional state
|
0.10%
2/2049
|
0.39%
8/2062
|
|
Psychiatric disorders
Delirium
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Psychiatric disorders
Depression
|
0.44%
9/2049
|
0.53%
11/2062
|
|
Psychiatric disorders
Drug dependence
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Major depression
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Mental disorder
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Psychiatric disorders
Mental status changes
|
0.15%
3/2049
|
0.10%
2/2062
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Mood swings
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Psychiatric disorders
Somatisation disorder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Psychiatric disorders
Suicide attempt
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Calculus bladder
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Calculus urinary
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2049
|
0.15%
3/2062
|
|
Renal and urinary disorders
Hydronephrosis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Renal colic
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Renal failure
|
0.05%
1/2049
|
0.34%
7/2062
|
|
Renal and urinary disorders
Renal failure acute
|
0.29%
6/2049
|
0.10%
2/2062
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Renal and urinary disorders
Urethral obstruction
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2049
|
0.19%
4/2062
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Anisomastia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Reproductive system and breast disorders
Breast mass
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Reproductive system and breast disorders
Breast oedema
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Cystocele
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Nipple exudate bloody
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.24%
5/2049
|
0.15%
3/2062
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Perineal pain
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Reproductive system and breast disorders
Uterine fistula
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.05%
1/2049
|
0.15%
3/2062
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
6/2049
|
0.44%
9/2062
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
10/2049
|
0.34%
7/2062
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
1/2049
|
0.10%
2/2062
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
5/2049
|
0.15%
3/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
6/2049
|
0.58%
12/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
3/2049
|
0.15%
3/2062
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.10%
2/2049
|
0.00%
0/2062
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Surgical and medical procedures
Breast lump removal
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Breast operation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.24%
5/2049
|
0.48%
10/2062
|
|
Surgical and medical procedures
Breast prosthesis removal
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Surgical and medical procedures
Breast reconstruction
|
1.2%
24/2049
|
0.78%
16/2062
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Mammoplasty
|
0.29%
6/2049
|
0.15%
3/2062
|
|
Surgical and medical procedures
Mastectomy
|
0.24%
5/2049
|
0.29%
6/2062
|
|
Surgical and medical procedures
Mechanical ventilation
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Surgical and medical procedures
Medical device removal
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Meniscus removal
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Modified radical mastectomy
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Surgical and medical procedures
Scar excision
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Surgical and medical procedures
Wound treatment
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Aortic dissection
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Vascular disorders
Aortic stenosis
|
0.10%
2/2049
|
0.05%
1/2062
|
|
Vascular disorders
Aortic thrombosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Arterial disorder
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Arterial occlusive disease
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Capillary fragility
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Circulatory collapse
|
0.15%
3/2049
|
0.19%
4/2062
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
2/2049
|
0.39%
8/2062
|
|
Vascular disorders
Embolism
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Extremity necrosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Femoral artery occlusion
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Haematoma
|
0.10%
2/2049
|
0.10%
2/2062
|
|
Vascular disorders
Haemorrhage
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Hypertension
|
0.34%
7/2049
|
0.19%
4/2062
|
|
Vascular disorders
Hypertensive crisis
|
0.20%
4/2049
|
0.00%
0/2062
|
|
Vascular disorders
Hypotension
|
0.15%
3/2049
|
0.05%
1/2062
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Iliac artery occlusion
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Lymphocele
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Lymphoedema
|
0.10%
2/2049
|
0.15%
3/2062
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Peripheral ischaemia
|
0.05%
1/2049
|
0.05%
1/2062
|
|
Vascular disorders
Peripheral vascular disorder
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/2049
|
0.05%
1/2062
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Thrombosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Varicose vein
|
0.00%
0/2049
|
0.10%
2/2062
|
|
Vascular disorders
Vena cava thrombosis
|
0.05%
1/2049
|
0.00%
0/2062
|
|
Vascular disorders
Venous thrombosis limb
|
0.05%
1/2049
|
0.00%
0/2062
|
Other adverse events
| Measure |
Letrozole
n=2049 participants at risk
Letrozole
|
Anastrozole
n=2062 participants at risk
Anastrozole
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
127/2049
|
7.2%
148/2062
|
|
General disorders
Fatigue
|
16.8%
345/2049
|
16.5%
341/2062
|
|
General disorders
Oedema peripheral
|
4.9%
100/2049
|
5.0%
104/2062
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
5.9%
120/2049
|
4.3%
88/2062
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.6%
155/2049
|
7.3%
151/2062
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
48.0%
983/2049
|
47.7%
983/2062
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
207/2049
|
9.1%
187/2062
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
138/2049
|
5.8%
120/2062
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
122/2049
|
7.0%
144/2062
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.3%
232/2049
|
10.2%
211/2062
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
9.9%
202/2049
|
8.3%
172/2062
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.8%
221/2049
|
10.9%
224/2062
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
167/2049
|
8.4%
174/2062
|
|
Nervous system disorders
Dizziness
|
4.5%
92/2049
|
5.2%
107/2062
|
|
Nervous system disorders
Headache
|
6.2%
127/2049
|
8.0%
164/2062
|
|
Psychiatric disorders
Depression
|
6.9%
141/2049
|
6.3%
129/2062
|
|
Psychiatric disorders
Insomnia
|
7.8%
160/2049
|
7.2%
149/2062
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
106/2049
|
5.8%
120/2062
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
111/2049
|
4.5%
92/2062
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
126/2049
|
6.5%
134/2062
|
|
Vascular disorders
Hot flush
|
32.5%
666/2049
|
32.3%
666/2062
|
|
Vascular disorders
Hypertension
|
7.4%
152/2049
|
7.0%
145/2062
|
|
Vascular disorders
Lymphoedema
|
7.7%
158/2049
|
8.6%
177/2062
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER