Trial Outcomes & Findings for Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis (NCT NCT00322439)

NCT ID: NCT00322439

Last Updated: 2018-06-28

Results Overview

A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).

• Recruitment status: COMPLETED
• Target enrollment: 2511 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2018-06-28

Participant Flow

Participant milestones

Measure	Etanercept Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Overall Study STARTED	2511
Overall Study Received at Least 1 Dose of Etanercept	2510
Overall Study COMPLETED	1455
Overall Study NOT COMPLETED	1056

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis

Baseline characteristics by cohort

Measure	Etanercept n=2510 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Age, Continuous	46.32 years STANDARD_DEVIATION 13.59 • n=5 Participants
Sex: Female, Male Female	1193 Participants n=5 Participants
Sex: Female, Male Male	1317 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	2052 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	108 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	164 participants n=5 Participants
Race/Ethnicity, Customized Asian	116 participants n=5 Participants
Race/Ethnicity, Customized Japanese	4 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	8 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	23 participants n=5 Participants
Race/Ethnicity, Customized Other	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).

Outcome measures

Measure	Etanercept n=2510 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events Serious Adverse Events	0.2029 proportion of participants Interval 0.1799 to 0.226
Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events Serious Infectious Events	0.0581 proportion of participants Interval 0.0447 to 0.0716

SECONDARY outcome

Timeframe: 5 years

Population: Full analysis set

Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.

Outcome measures

Measure	Etanercept n=2510 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Malignancy, including BCC, SCC and lymphoma	0.0659 proportion of participants Interval 0.0538 to 0.078
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Coronary artery disease	0.0283 proportion of participants Interval 0.0202 to 0.0364
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Worsening of psoriasis	0.0074 proportion of participants Interval 0.0032 to 0.0115
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) CNS demyelinating disorder	0.0018 proportion of participants Interval -0.0002 to 0.0039
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Tuberculosis	0.0013 proportion of participants Interval -0.0005 to 0.003
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Lupus disease	0.0006 proportion of participants Interval -0.0006 to 0.0018
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Opportunistic infection	0.0006 proportion of participants Interval -0.0006 to 0.0018
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Coccidioidomycosis	NA proportion of participants There were no events in this category
Five-year Cumulative Incidence for Events of Medical Interest (EMIs) Histoplasmosis	NA proportion of participants There were no events in this category

SECONDARY outcome

Timeframe: Baseline and at 3 and 5 years

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) Baseline (n=2472)	12.0 percentage of participants
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) 3 years (n= 1456)	47.4 percentage of participants
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) 5 years (n=1269)	51.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and at 3 and 5 years

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 Baseline (n=2435)	11.4 percentage of participants
Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 3 years (n= 1446)	53.2 percentage of participants
Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 5 years (n=1322)	55.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response Year 3 (n=1453)	60.2 percentage of participants
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response Year 5 (n=1319)	64.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Euroqol-5D (EQ-5D) Total Score Baseline (n=2440)	0.78 units on a scale Standard Error 0.0
Euroqol-5D (EQ-5D) Total Score Year 3 (n=1454)	0.86 units on a scale Standard Error 0.0
Euroqol-5D (EQ-5D) Total Score Year 5 (n=1322)	0.86 units on a scale Standard Error 0.0

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) Year 3 (n=1462)	81.81 units on a scale Standard Error 0.42
Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) Year 5 (n=1328)	82.51 units on a scale Standard Error 0.44
Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) Baseline (n=2446)	74.05 units on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:

1. How many times have you been to any physician's office or urgent care clinic, not including your dermatologist?

2. How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?

3. How many times have you received care from a health professional (HP) in your home?

4. How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?

5. How many times have you had a friend or family member take time off work to provide care or transportation?

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Healthcare Resource Use Baseline: Physician/urgent care visits (n=2423)	0.72 times Standard Error 0.0
Healthcare Resource Use Baseline: Nurse practitioner, etc visits (n=2418)	0.35 times Standard Error 0.0
Healthcare Resource Use Baseline: Home care from a HP (n=2411)	0.03 times Standard Error 0.0
Healthcare Resource Use Baseline: Paid help with chores (n=2414)	0.46 times Standard Error 0.0
Healthcare Resource Use Baseline: Friend or family provided care (n=2415)	0.26 times Standard Error 0.0
Healthcare Resource Use Year 3: Physician/urgent care visits (n=1458)	0.63 times Standard Error 0.0
Healthcare Resource Use Year 3: Nurse practitioner, etc visits (n=1451)	0.29 times Standard Error 0.0
Healthcare Resource Use Year 3: Home care visits from a HP (n=1451)	0.03 times Standard Error 0.0
Healthcare Resource Use Year 3: Paid help with chores (n=1451)	0.42 times Standard Error 0.0
Healthcare Resource Use Year 3: Friend or family provided care (n=1453)	0.12 times Standard Error 0.0
Healthcare Resource Use Year 5: Physician/urgent care visits (n=1317)	0.64 times Standard Error 0.0
Healthcare Resource Use Year 5: Nurse practitioner, etc visits (n=1318)	0.27 times Standard Error 0.0
Healthcare Resource Use Year 5: Home care visits from a HP (n=1317)	0.06 times Standard Error 0.0
Healthcare Resource Use Year 5: Paid help with chores (n=1318)	0.44 times Standard Error 0.1
Healthcare Resource Use Year 5: Friend or family provided care (n=1318)	0.17 times Standard Error 0.0

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores).

The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Work Productivity and Activity Impairment (WPAI) Absenteeism - Baseline (n=1709)	2.81 units on a scale Standard Error 0.28
Work Productivity and Activity Impairment (WPAI) Absenteeism - Year 3 (n=949)	1.34 units on a scale Standard Error 0.23
Work Productivity and Activity Impairment (WPAI) Absenteeism - Year 5 (n=808)	1.47 units on a scale Standard Error 0.32
Work Productivity and Activity Impairment (WPAI) Presenteeism - Baseline (n=1832)	18.50 units on a scale Standard Error 0.57
Work Productivity and Activity Impairment (WPAI) Presenteeism - Year 3 (n=1009)	9.00 units on a scale Standard Error 0.59
Work Productivity and Activity Impairment (WPAI) Presenteeism - Year 5 (n=866)	7.90 units on a scale Standard Error 0.58
Work Productivity and Activity Impairment (WPAI) Work Productivity Loss - Baseline (n=1702)	18.82 units on a scale Standard Error 0.60
Work Productivity and Activity Impairment (WPAI) Work Productivity Loss - Year 3 (n=944)	9.58 units on a scale Standard Error 0.63
Work Productivity and Activity Impairment (WPAI) Work Productivity Loss - Year 5 (n=805)	8.55 units on a scale Standard Error 0.65
Work Productivity and Activity Impairment (WPAI) Activity Impairment - Baseline (n=2440)	25.37 units on a scale Standard Error 0.57
Work Productivity and Activity Impairment (WPAI) Activity Impairment - Year 3 (n=1460)	12.01 units on a scale Standard Error 0.55
Work Productivity and Activity Impairment (WPAI) Activity Impairment - Year 5 (n=1322)	11.29 units on a scale Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline, Year 3 and Year 5

Population: Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).

Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.

Outcome measures

Measure	Etanercept n=2493 Participants Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Percentage of Body Surface Area Affected by Psoriasis Baseline (n=2478)	21.06 percentage of body surface area Standard Error 0.39
Percentage of Body Surface Area Affected by Psoriasis Year 3 (n=1455)	6.59 percentage of body surface area Standard Error 0.28
Percentage of Body Surface Area Affected by Psoriasis Year 5 (n=1269)	6.06 percentage of body surface area Standard Error 0.30

Adverse Events

Etanercept

Serious events: 418 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept n=2510 participants at risk Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Blood and lymphatic system disorders Anaemia	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukocytosis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute Coronary Syndrome	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute Myocardial Infarction	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina Pectoris	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina Unstable	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Aortic Valve Disease	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arteriosclerosis Coronary Artery	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial Fibrillation	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac Arrest	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac Failure	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac Failure Congestive	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiomyopathy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary Artery Disease	0.56% 14/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary Artery Insufficiency	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary Artery Occlusion	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary Artery Stenosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Extrasystoles	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Heart Valve Incompetence	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral Valve Incompetence	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral Valve Prolapse	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial Infarction	0.68% 17/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Adrenoleukodystrophy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Vertigo	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Autoimmune Thyroiditis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hyperparathyroidism	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hyperthyroidism	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Ophthalmoplegia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Visual Acuity Reduced	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal Adhesions	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal Hernia	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal Pain	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal Pain Upper	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal Strangulated Hernia	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Alcoholic Pancreatitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Anal Fissure	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Crohn's Disease	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticulum Gastric	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Faeces Discoloured	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric Volvulus	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal Necrosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Hiatus Hernia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal Haemorrhage	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal Obstruction	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Large Intestine Perforation	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal Stenosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.24% 6/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis Acute	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small Intestinal Obstruction	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical Hernia	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical Hernia, Obstructive	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest Discomfort	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Cyst	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Death	0.68% 17/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device Malfunction	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Generalised Oedema	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection Site Urticaria	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Medical Device Complication	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Multi-Organ Failure	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Non-Cardiac Chest Pain	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Biliary Dyskinesia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis Acute	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Chronic Hepatic Failure	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cirrhosis Alcoholic	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic Cirrhosis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic Function Abnormal	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatitis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatitis Alcoholic	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Drug Hypersensitivity	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Hypersensitivity	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess Intestinal	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess Limb	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Appendicitis	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arteriovenous Graft Site Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Beta Haemolytic Streptococcal Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	0.88% 22/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Chest Wall Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cholecystitis Infective	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridial Infection	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium Difficile Colitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium Difficile Sepsis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	0.44% 11/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Dural Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Erysipelas	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia Sepsis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia Urinary Tract Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Folliculitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Hepatitis C	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes Zoster	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infectious Mononucleosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Injection Site Cellulitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Kidney Infection	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Klebsiella Bacteraemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Latent Tuberculosis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Liver Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Localised Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Mastitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningitis Aseptic	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningitis Listeria	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningitis Streptococcal	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Necrotising Fasciitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Osteomyelitis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pelvic Inflammatory Disease	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Perirectal Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Peritonitis Bacterial	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	1.2% 30/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia Bacterial	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia Staphylococcal	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Post Procedural Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pyelonephritis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Septic Shock	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal Bacteraemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal Infection	0.28% 7/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Subcutaneous Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tooth Abscess	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Toxic Shock Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tuberculosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary Tract Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urosepsis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Viral Infection	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Wound Infection Staphylococcal	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Anaemia Postoperative	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Concussion	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Craniocerebral Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Crushing Injury Of Trunk	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	0.24% 6/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Foot Fracture	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fractured Sacrum	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Hand Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Head Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Hip Fracture	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Intentional Overdose	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint Injury	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Laceration	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ligament Rupture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Meniscus Lesion	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Muscle Strain	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Nail Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Patella Fracture	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pelvic Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pubis Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Rib Fracture	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Road Traffic Accident	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Subdural Haematoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tendon Rupture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Traumatic Renal Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Upper Limb Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ureteric Injury	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Wrist Fracture	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Anticonvulsant Drug Level Increased	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Antinuclear Antibody Positive	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood Creatinine Increased	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Lipase Increased	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Tuberculin Test Positive	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations White Blood Cell Count Increased	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased Appetite	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	0.24% 6/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes Mellitus	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Electrolyte Imbalance	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Failure To Thrive	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperlipidaemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Obesity	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back Pain	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bursitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Kyphoscoliosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck Pain	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.56% 14/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Synovitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous Cell Lung Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B Precursor Type Acute Leukaemia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Hepatic Neoplasm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Uterine Neoplasm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Stromal Tumour	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Carcinoma Of The Respiratory Tract Stage Unspecified	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip And/Or Oral Cavity Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Liver	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Renal Cell Carcinoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis Fungoides	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma Stage 0	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Precursor B-Lymphoblastic Lymphoma Recurrent	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Stage 0	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Stage Unspecified	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer Metastatic	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer Stage I	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Arachnoid Cyst	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Arachnoiditis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Balance Disorder	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Benign Intracranial Hypertension	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carotid Artery Occlusion	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carotid Artery Stenosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular Accident	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Convulsion	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dementia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Diabetic Neuropathy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Epilepsy	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hepatic Encephalopathy	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoaesthesia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Intracranial Aneurysm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Intracranial Pressure Increased	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Ischaemic Stroke	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Loss Of Consciousness	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Multiple Sclerosis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuropathy Peripheral	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Parkinson's Disease	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Peripheral Sensorimotor Neuropathy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Presyncope	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Radicular Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Radiculopathy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Sciatica	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Thoracic Outlet Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Transient Ischaemic Attack	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Tremor	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Pregnancy, puerperium and perinatal conditions Complication Of Pregnancy	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Pregnancy, puerperium and perinatal conditions Pre-Eclampsia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Adjustment Disorder With Mixed Disturbance Of Emotion And Conduct	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Aggression	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Bipolar Disorder	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Completed Suicide	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Delirium	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Major Depression	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Mental Status Changes	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Psychotic Disorder	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Suicidal Ideation	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Suicide Attempt	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Calculus Ureteric	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Glomerulonephritis Membranous	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Haematuria	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Nephrolithiasis	0.28% 7/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal Aneurysm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal Failure	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal Failure Acute	0.24% 6/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal Failure Chronic	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Endometrial Hyperplasia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Menometrorrhagia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Ovarian Cyst	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Ovarian Mass	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Polycystic Ovaries	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Prostatitis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Uterine Polyp	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.32% 8/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Idiopathic Pulmonary Fibrosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pickwickian Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.16% 4/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis Exfoliative	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Psoriasis	0.12% 3/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin Ulcer	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Caesarean Section	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Aortic Aneurysm	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Aortic Dissection	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Arteriosclerosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep Vein Thrombosis	0.20% 5/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	0.24% 6/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.08% 2/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Intermittent Claudication	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral Arterial Occlusive Disease	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral Vascular Disorder	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Superior Vena Cava Syndrome	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Thrombosis	0.04% 1/2510 • 5 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

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

Restriction type: OTHER