Trial Outcomes & Findings for Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials (NCT NCT00357903)

NCT ID: NCT00357903

Last Updated: 2017-02-09

Results Overview

Total participant exposure to etanercept (Enbrel) with gaps

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 639 participants
• Primary outcome timeframe: Up to 10 years
• Results posted on: 2017-02-09

Participant Flow

Participants were enrolled from 31 July 1997 through 12 Oct 1999

Participant milestones

Measure	Adult Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Overall Study STARTED	581	58
Overall Study COMPLETED	218	15
Overall Study NOT COMPLETED	363	43

Reasons for withdrawal

Measure	Adult Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Overall Study Adverse Event	87	4
Overall Study Death	33	0
Overall Study Lost to Follow-up	23	4
Overall Study Physician Decision	39	5
Overall Study Withdrawal by Subject	57	7
Overall Study Completed month 12 only	0	1
Overall Study Protocol issues	14	3
Overall Study Response status	61	9
Overall Study Other	49	10

Baseline Characteristics

Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

Baseline characteristics by cohort

Measure	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Total n=639 Participants Total of all reporting groups
Age, Continuous	11.02 Years STANDARD_DEVIATION 3.80 • n=5 Participants	52.87 Years STANDARD_DEVIATION 12.03 • n=7 Participants	49.07 Years STANDARD_DEVIATION 16.66 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	465 Participants n=7 Participants	504 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	116 Participants n=7 Participants	135 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participant n=5 Participants	4 Participant n=7 Participants	5 Participant n=5 Participants
Race/Ethnicity, Customized Asian	1 Participant n=5 Participants	10 Participant n=7 Participants	11 Participant n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participant n=5 Participants	18 Participant n=7 Participants	22 Participant n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	9 Participant n=5 Participants	25 Participant n=7 Participants	34 Participant n=5 Participants
Race/Ethnicity, Customized White or Caucasian	43 Participant n=5 Participants	522 Participant n=7 Participants	565 Participant n=5 Participants
Race/Ethnicity, Customized Other	0 Participant n=5 Participants	2 Participant n=7 Participants	2 Participant n=5 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Total participant exposure to etanercept (Enbrel) with gaps

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure to Etanercept With Gaps	4033.07 Participant-years	341.98 Participant-years

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure Adjusted Rate of Malignancies	1.41 Malignancies per 100 participant-years	0.00 Malignancies per 100 participant-years

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure Adjusted Rate of Deaths	0.57 Deaths per 100 participant-years	0.00 Deaths per 100 participant-years

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure Adjusted Rate of Serious Infectious Events	5.18 Events per 100 participant-years	3.22 Events per 100 participant-years

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure Adjusted Rate of Lymphomas	0.15 Lymphomas per 100 participant-years	0.00 Lymphomas per 100 participant-years

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Malignancy	48 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Lymphoma	6 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Serious Infectious Event	114 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Occurrence of death on study within 30 days of the last dose of etanercept

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Death	23 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Total Exposure Adjusted Rate of Serious Adverse Events	20.95 Events per 100 participant-years	12.87 Events per 100 participant-years

SECONDARY outcome

Timeframe: Up to 10 years

Population: All participants who received at least one dose of etanercept

Duration of etanercept dosing

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Dosing Period	2535.4 Days Standard Deviation 1433.77	2153.6 Days Standard Deviation 1379.15

SECONDARY outcome

Timeframe: Month 12

Population: All participants who received at least one dose of etanercept and had available data

Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation

Outcome measures

Measure	Adult Participants n=509 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=15 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Tender Joint Count	9.55 Joints Standard Deviation 10.97	11.60 Joints Standard Deviation 10.61

SECONDARY outcome

Timeframe: Month 12

Population: All participants who received at least one dose of etanercept and had available data

Number of swollen joints

Outcome measures

Measure	Adult Participants n=510 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=28 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Swollen Joint Count	9.14 Joints Standard Deviation 8.83	11.93 Joints Standard Deviation 11.86

SECONDARY outcome

Timeframe: Month 12

Population: All participants who received at least one dose of etanercept and had available data

Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).

Outcome measures

Measure	Adult Participants n=485 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Health Assessment Questionnaire Disability Index	0.96 Units on a scale Standard Deviation 0.71	—

SECONDARY outcome

Timeframe: Month 12

Population: All participants who received at least one dose of etanercept and had available data

Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).

Outcome measures

Measure	Adult Participants n=46 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Childhood Health Assessment Questionnaire	1.08 Units on a scale Standard Deviation 0.95	—

SECONDARY outcome

Timeframe: Month 12

Population: All participants who received at least one dose of etanercept and had available data

C-reactive protein at month 12

Outcome measures

Measure	Adult Participants n=509 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=48 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
C-Reactive Protein	1.37 mg/dL Standard Deviation 1.85	2.11 mg/dL Standard Deviation 3.82

SECONDARY outcome

Timeframe: Baseline and month 3

Population: All participants who received at least one dose of etanercept and had available data at both baseline and month 3

American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults

Outcome measures

Measure	Adult Participants n=560 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
ACR20 at Month 3 in Adults	372 Participants	—

SECONDARY outcome

Timeframe: Baseline and month 3

Population: All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months

Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.

Outcome measures

Measure	Adult Participants n=53 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
JRA DOI 30 at Month 3 in Juveniles	46 Participants	—

SECONDARY outcome

Timeframe: up to 10 years

Population: All participants who received at least one dose of etanercept

Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.

Outcome measures

Measure	Adult Participants n=581 Participants Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly	Pediatric Participants n=58 Participants Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
Standardized Incidence Rate for All SEER Cancers	1.30 Observed count / expected count	0.00 Observed count / expected count

Adverse Events

Total Adults

Serious events: 293 serious events

Other events: 484 other events

Deaths: 0 deaths

Pediatric Subjects

Serious events: 16 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Adults n=581 participants at risk	Pediatric Subjects n=58 participants at risk
Gastrointestinal disorders Vomiting	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Adverse event	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest discomfort	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	1.7% 10/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Condition aggravated	4.3% 25/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Death	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Impaired healing	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Necrosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Non-cardiac chest pain	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Sudden death	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Autoimmune hepatitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis acute	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic failure	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatitis alcoholic	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Perforation bile duct	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Allergy to arthropod sting	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Coagulopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Splenic infarction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute myocardial infarction	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina pectoris	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia supraventricular	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	1.2% 7/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial flutter	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	2.2% 13/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardio-respiratory arrest	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery disease	2.1% 12/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery occlusion	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cyanosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Diastolic dysfunction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ischaemic cardiomyopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Left ventricular dysfunction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	3.4% 20/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocarditis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericarditis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sick sinus syndrome	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Supraventricular tachycardia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular fibrillation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular tachycardia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Adrenal insufficiency	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal hernia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal hernia obstructive	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.4% 2/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis ischaemic	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis ulcerative	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticular perforation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticulum oesophageal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastroduodenitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Hiatus hernia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal obstruction	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Large intestine perforation	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal rupture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal stenosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal ulcer	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Rectal prolapse	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Retroperitoneal haematoma	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Anaphylactic reaction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Drug hypersensitivity	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Sarcoidosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess intestinal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess limb	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Appendicitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arthritis bacterial	1.5% 9/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arthritis infective	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Atypical mycobacterial infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchopneumonia	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bursitis infective	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	3.3% 19/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis staphylococcal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis streptococcal	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium difficile colitis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diarrhoea infectious	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	1.2% 7/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Enterocolitis infectious	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia bacteraemia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia urinary tract infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Fungal sepsis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis viral	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastrointestinal infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Graft infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Hepatitis B	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes zoster	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.4% 2/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Incisional hernia gangrenous	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infection	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Kidney infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Localised infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lung infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningitis aseptic	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Meningococcal sepsis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Osteomyelitis	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Peritonitis bacterial	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumococcal sepsis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	6.2% 36/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Post procedural infection	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Post procedural pneumonia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Postoperative wound infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Proteus infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pseudomembranous colitis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pyelonephritis	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	1.7% 10/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis syndrome	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Septic shock	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Shigella infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Skin infection	2.4% 14/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.4% 2/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Soft tissue infection	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal infection	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal skin infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Streptococcal infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Subcutaneous abscess	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tooth abscess	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Toxic shock syndrome streptococcal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection enterococcal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urosepsis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Viral infection	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ankle fracture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Caustic injury	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Chest injury	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Compression fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Device malfunction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Extradural haematoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Eye injury	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Facial bones fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	1.4% 8/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femoral neck fracture	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur fracture	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fibula fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Foot fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Hand fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Hip fracture	1.4% 8/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Humerus fracture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Injury	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Jaw fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint dislocation	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint injury	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lower limb fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Medical device complication	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Muscle strain	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Open fracture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pelvic fracture	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Radius fracture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Soft tissue injury	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Thermal burn	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tibia fracture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Wound	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Arteriogram coronary	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood pressure abnormal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood pressure increased	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Bone density decreased	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Cardiac ventriculogram left	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Catheterisation cardiac	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Heart rate abnormal	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Oxygen saturation decreased	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	1.2% 7/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetic foot	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 8/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bone pain	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Costochondritis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Flank pain	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Foot deformity	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Hand deformity	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Joint effusion	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Juvenile arthritis	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.4% 2/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Limb discomfort	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Low turnover osteopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle necrosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myositis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.6% 15/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteolysis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pelvic deformity	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	4.8% 28/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.3% 6/58 • Up to 11.29 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	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Synovial cyst	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Synovitis	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Acute myeloid leukaemia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Bile duct cancer	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 transitional cell carcinoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 female	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 in situ	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Bronchial carcinoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Cervix carcinoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Cervix carcinoma stage 0	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 recurrent	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Follicle centre lymphoma diffuse small cell lymphoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 tract adenoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Gliosarcoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Histiocytosis haematophagic	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.4% 2/58 • Up to 11.29 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) Hodgkin's disease	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Laryngeal cancer	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Laryngeal cancer stage I	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Lentigo maligna stage unspecified	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Lymphocytic leukaemia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Lymphocytic lymphoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Meningioma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Meningioma benign	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 ovary	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 small intestine	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Non-Hodgkin's lymphoma	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Non-small cell lung cancer	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Non-small cell lung cancer stage I	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 metastatic	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 epithelial cancer	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Prolymphocytic leukaemia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Squamous cell carcinoma	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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) Squamous cell carcinoma of skin	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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 neoplasm	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Brain stem infarction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carpal tunnel syndrome	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral thrombosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	1.2% 7/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hemiparesis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoaesthesia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Intracranial aneurysm	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lumbar radiculopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Multiple sclerosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Radiculopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Transient ischaemic attack	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Bipolar disorder	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Mental disorder	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Calculus ureteric	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Nephrolithiasis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal tubular necrosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Uterine polyp	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Vaginal erythema	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Vaginal haemorrhage	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 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	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Diffuse alveolar damage	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 7/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Angioedema	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermal cyst	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Panniculitis	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin lesion	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin ulcer	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Social circumstances Joint prosthesis user	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Cardiac ablation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Cholecystectomy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Fracture treatment	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Hip arthroplasty	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Joint arthroplasty	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Knee arthroplasty	0.69% 4/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Leg amputation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Shoulder arthroplasty	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Shoulder operation	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Angiopathy	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Aortic aneurysm rupture	0.34% 2/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Circulatory collapse	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep vein thrombosis	1.0% 6/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Haemorrhage	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Infarction	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Orthostatic hypotension	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral arterial occlusive disease	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral embolism	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral ischaemia	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral vascular disorder	0.17% 1/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Shock	0.00% 0/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Total Adults n=581 participants at risk	Pediatric Subjects n=58 participants at risk
Gastrointestinal disorders Abdominal pain	4.3% 25/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 5/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	2.6% 15/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.1% 7/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	9.0% 52/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	6.4% 37/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	6.9% 40/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 5/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	2.2% 13/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	6.2% 36/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site erythema	11.2% 65/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.8% 8/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site pain	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site pruritus	6.7% 39/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site swelling	4.3% 25/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.3% 6/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	1.5% 9/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.3% 6/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	15.3% 89/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Conjunctivitis infective	3.3% 19/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cystitis	9.8% 57/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Ear infection	2.1% 12/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis viral	2.9% 17/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 4/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	10.3% 60/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.1% 7/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Otitis media	2.9% 17/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 5/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pharyngitis	5.2% 30/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.4% 13/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pharyngitis streptococcal	0.86% 5/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 5/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	5.3% 31/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 1/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	20.8% 121/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.8% 8/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Skin infection	14.5% 84/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.5% 9/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	35.6% 207/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.1% 36/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	3.6% 21/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	9.1% 53/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	6.2% 36/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	13.8% 80/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	34.5% 20/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Migraine	2.2% 13/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	6.5% 38/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 17/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.52% 3/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 3/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.2% 13/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 5/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	8.6% 50/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.1% 7/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	6.0% 35/581 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/58 • Up to 11.29 years The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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 after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER