Time Frame |
All-cause mortality: Day 1 to Day 1095 (Arms 1, 2); Day 365 to Day 730 (Arms 3, 4); Day 730 to Day 1095 (Arms 5 to 9); Day 1095 to Day 1460 (Arms 10 to 14); Serious/other AEs: Day 1 to Day 1095 (Arms 1, 2), 6 months after revacc at Day 365 (Arms 3, 4): up to Day 547, 6 months after revacc at Day 730 (Arms 5 to 9): up to Day 912, 6 months after revacc at Day 1095 (Arms 10 to 14): up to Day 1277
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Adverse Event Reporting Description |
All-cause mortality and SAEs analyzed based on FAS population which included all randomized participants with a documented vaccine administration, regardless of occurrence of protocol deviations. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed in safety subset (subset of FAS) for main cohorts and in FAS for revaccination subcohorts. The safety subset included all participants that consented to the collection of AEs (solicited and unsolicited AEs).
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Arm/Group Title
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Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
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Arm 2: Main Cohort: Group 2: Placebo
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Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
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Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
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Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
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Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm/Group Description |
Adult participants aged greater tha...
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Adult participants aged >=65 years ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Eligible participants who received ...
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Arm/Group Description |
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
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Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
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Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
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Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
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Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
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Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
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Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
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Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
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Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
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Arm 2: Main Cohort: Group 2: Placebo
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Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
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Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
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Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
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Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
39/2891 (1.35%) |
38/2891 (1.31%) |
1/120 (0.83%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
2/149 (1.34%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
1/119 (0.84%) |
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Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
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Arm 2: Main Cohort: Group 2: Placebo
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Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
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Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
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Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
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Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
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Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
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|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
203/2891 (7.02%) |
196/2891 (6.78%) |
2/120 (1.67%) |
6/126 (4.76%) |
0/28 (0.00%) |
3/28 (10.71%) |
1/28 (3.57%) |
4/137 (2.92%) |
6/149 (4.03%) |
2/37 (5.41%) |
0/37 (0.00%) |
0/37 (0.00%) |
2/131 (1.53%) |
2/119 (1.68%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Anaemia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Blood Loss Anaemia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Splenic Infarction |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
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Acute Coronary Syndrome |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Acute Left Ventricular Failure |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Acute Myocardial Infarction |
1/2891 (0.03%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Angina Unstable |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Aortic Valve Disease |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Aortic Valve Stenosis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Arrhythmia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Arteriosclerosis Coronary Artery |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Atrial Fibrillation |
10/2891 (0.35%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Atrial Flutter |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/137 (0.73%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Bradycardia |
1/2891 (0.03%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cardiac Arrest |
2/2891 (0.07%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cardiac Failure |
1/2891 (0.03%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cardiac Failure Congestive |
9/2891 (0.31%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
1/119 (0.84%) |
Cardiomyopathy |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Coronary Artery Disease |
2/2891 (0.07%) |
5/2891 (0.17%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/131 (0.76%) |
0/119 (0.00%) |
Ischaemic Cardiomyopathy |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Left Ventricular Failure |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Myocardial Infarction |
8/2891 (0.28%) |
9/2891 (0.31%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/131 (0.76%) |
0/119 (0.00%) |
Myocardial Ischaemia |
2/2891 (0.07%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Stress Cardiomyopathy |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ventricular Tachycardia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertigo |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypothyroidism |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Inappropriate Antidiuretic Hormone Secretion |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal Pain |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ascites |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Colitis |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diarrhoea |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Duodenal Ulcer Haemorrhage |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Food Poisoning |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Gastric Perforation |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Gastrointestinal Haemorrhage |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hiatus Hernia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Inguinal Hernia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Intestinal Obstruction |
3/2891 (0.10%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Intestinal Perforation |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Large Intestinal Obstruction |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Nausea |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Obstructive Pancreatitis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Oesophageal Obstruction |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Oesophageal Perforation |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Oesophagitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatic Cyst |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/137 (0.73%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatic Mass |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatitis Acute |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Rectal Prolapse |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Small Intestinal Obstruction |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Upper Gastrointestinal Haemorrhage |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Vomiting |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adverse Drug Reaction |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Asthenia |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Chest Discomfort |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Chest Pain |
1/2891 (0.03%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Death |
7/2891 (0.24%) |
4/2891 (0.14%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Drowning |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Generalised Oedema |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Multiple Organ Dysfunction Syndrome |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Non-Cardiac Chest Pain |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholecystitis |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cholelithiasis |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cirrhosis Alcoholic |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abscess Neck |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Alpha Haemolytic Streptococcal Infection |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Appendicitis |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Bronchitis |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cellulitis |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Clostridium Difficile Colitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Covid-19 |
13/2891 (0.45%) |
13/2891 (0.45%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Covid-19 Pneumonia |
13/2891 (0.45%) |
16/2891 (0.55%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cystitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Device Related Infection |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diabetic Foot Infection |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diverticulitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Gangrene |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Influenza |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Kidney Infection |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Meningitis Aseptic |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Osteomyelitis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Periorbital Cellulitis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia |
16/2891 (0.55%) |
10/2891 (0.35%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia Aspiration |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia Bacterial |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia Chlamydial |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia Mycoplasmal |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumonia Parainfluenzae Viral |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pyelonephritis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Sepsis |
3/2891 (0.10%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Septic Shock |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Streptococcal Sepsis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Tonsillitis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Urinary Tract Infection |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ankle Fracture |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Carbon Monoxide Poisoning |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cervical Vertebral Fracture |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Craniocerebral Injury |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Environmental Exposure |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Extradural Haematoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Facial Bones Fracture |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Femoral Neck Fracture |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Femur Fracture |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Fracture Displacement |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Head Injury |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hip Fracture |
3/2891 (0.10%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Humerus Fracture |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/137 (0.73%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypobarism |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lumbar Vertebral Fracture |
3/2891 (0.10%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Post Procedural Complication |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Road Traffic Accident |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Scapula Fracture |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Skin Abrasion |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Spinal Compression Fracture |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Spinal Fracture |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Subdural Haematoma |
3/2891 (0.10%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Tibia Fracture |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Traumatic Fracture |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Upper Limb Fracture |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Wound Dehiscence |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/137 (0.73%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Wrist Fracture |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adult Failure to Thrive |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Dehydration |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diabetes Mellitus |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diabetic Ketoacidosis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hyperglycaemia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hyperkalaemia |
1/2891 (0.03%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypoglycaemia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hyponatraemia |
1/2891 (0.03%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypovolaemia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Type 2 Diabetes Mellitus |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cervical Spinal Stenosis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Chondrocalcinosis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Intervertebral Disc Protrusion |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Kyphoscoliosis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Musculoskeletal Chest Pain |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Osteoarthritis |
7/2891 (0.24%) |
6/2891 (0.21%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Rhabdomyolysis |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Rotator Cuff Syndrome |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Spinal Stenosis |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal Neoplasm |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Acute Myeloid Leukaemia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Adenocarcinoma of Colon |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Bladder Cancer |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Bladder Transitional Cell Carcinoma |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Brain Neoplasm |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Breast Cancer |
1/2891 (0.03%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cancer Pain |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Endometrial Adenocarcinoma |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hepatic Cancer |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hepatocellular Carcinoma |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Her2 Positive Breast Cancer |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Intraductal Proliferative Breast Lesion |
3/2891 (0.10%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Invasive Ductal Breast Carcinoma |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lung Adenocarcinoma |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lung Carcinoma Cell Type Unspecified Stage Iii |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lung Carcinoma Cell Type Unspecified Stage Iv |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lung Neoplasm Malignant |
3/2891 (0.10%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Marginal Zone Lymphoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metastases to Liver |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metastatic Malignant Melanoma |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metastatic Squamous Cell Carcinoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Non-Hodgkin's Lymphoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Non-Small Cell Lung Cancer |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Oesophageal Carcinoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ovarian Adenoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ovarian Cancer |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatic Carcinoma |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pancreatic Carcinoma Stage Iv |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Papillary Serous Endometrial Carcinoma |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Prostate Cancer |
4/2891 (0.14%) |
4/2891 (0.14%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
1/119 (0.84%) |
Prostate Cancer Metastatic |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal Cancer |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal Cell Carcinoma |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Small Cell Lung Cancer Extensive Stage |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Throat Cancer |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Transitional Cell Cancer of the Renal Pelvis and Ureter |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Transitional Cell Carcinoma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Uterine Cancer |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Waldenstrom's Macroglobulinaemia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ataxia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Autonomic Neuropathy |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Carotid Artery Stenosis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cerebral Haemorrhage |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cerebral Ischaemia |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cerebrovascular Accident |
2/2891 (0.07%) |
2/2891 (0.07%) |
1/120 (0.83%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Encephalopathy |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypoaesthesia |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Intracranial Aneurysm |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ischaemic Stroke |
3/2891 (0.10%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lacunar Infarction |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Lumbar Radiculopathy |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metabolic Encephalopathy |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Myelopathy |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Peroneal Nerve Palsy |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Presyncope |
1/2891 (0.03%) |
3/2891 (0.10%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Sciatica |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Seizure |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Subarachnoid Haemorrhage |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Syncope |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
1/119 (0.84%) |
Toxic Encephalopathy |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Transient Ischaemic Attack |
0/2891 (0.00%) |
4/2891 (0.14%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Tremor |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Trigeminal Neuralgia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alcoholism |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Anxiety |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Bipolar Disorder |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Depression Suicidal |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Major Depression |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Mental Status Changes |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute Kidney Injury |
2/2891 (0.07%) |
2/2891 (0.07%) |
1/120 (0.83%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Chronic Kidney Disease |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hydronephrosis |
0/2891 (0.00%) |
2/2891 (0.07%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Nephrolithiasis |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Neurogenic Bladder |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal Colic |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal Failure |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Renal Injury |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ureterolithiasis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benign Prostatic Hyperplasia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Postmenopausal Haemorrhage |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Prostatitis |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute Respiratory Distress Syndrome |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Acute Respiratory Failure |
7/2891 (0.24%) |
6/2891 (0.21%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Asthma |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Chronic Obstructive Pulmonary Disease |
10/2891 (0.35%) |
4/2891 (0.14%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Dyspnoea |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypoxia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pleural Effusion |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pneumothorax |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pulmonary Embolism |
3/2891 (0.10%) |
5/2891 (0.17%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pulmonary Fibrosis |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pulmonary Haemorrhage |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pulmonary Oedema |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Respiratory Failure |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Surgical and medical procedures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rotator Cuff Repair |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aortic Aneurysm |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Aortic Stenosis |
2/2891 (0.07%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Arteriosclerosis |
2/2891 (0.07%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Endothelial Dysfunction |
1/2891 (0.03%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypertensive Urgency |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypotension |
1/2891 (0.03%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Peripheral Arterial Occlusive Disease |
0/2891 (0.00%) |
0/2891 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/137 (0.73%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Peripheral Ischaemia |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Vascular Compression |
0/2891 (0.00%) |
1/2891 (0.03%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Term from vocabulary, MedDRA Version 25.1
Indicates events were collected by non-systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
2%
|
|
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
|
Arm 2: Main Cohort: Group 2: Placebo
|
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
|
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
|
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
|
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
|
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
|
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
186/348 (53.45%) |
90/347 (25.94%) |
47/120 (39.17%) |
47/126 (37.30%) |
15/28 (53.57%) |
21/28 (75.00%) |
21/28 (75.00%) |
110/137 (80.29%) |
111/149 (74.50%) |
30/37 (81.08%) |
22/37 (59.46%) |
34/37 (91.89%) |
107/131 (81.68%) |
84/119 (70.59%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iron Deficiency Anaemia |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angina Pectoris |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
2/37 (5.41%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Aortic Valve Incompetence |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Atrial Fibrillation |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Atrial Flutter |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Mitral Valve Incompetence |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Tricuspid Valve Incompetence |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertigo |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constipation |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Dental Caries |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/131 (0.00%) |
0/119 (0.00%) |
Diarrhoea |
4/348 (1.15%) |
1/347 (0.29%) |
0/120 (0.00%) |
0/126 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Dyspepsia |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Nausea (Solicited) |
31/348 (8.91%) |
7/347 (2.02%) |
4/120 (3.33%) |
5/126 (3.97%) |
0/28 (0.00%) |
3/28 (10.71%) |
0/28 (0.00%) |
10/137 (7.30%) |
22/149 (14.77%) |
3/37 (8.11%) |
1/37 (2.70%) |
4/37 (10.81%) |
9/131 (6.87%) |
12/119 (10.08%) |
Plicated Tongue |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue (Solicited) |
95/348 (27.30%) |
42/347 (12.10%) |
19/120 (15.83%) |
24/126 (19.05%) |
4/28 (14.29%) |
6/28 (21.43%) |
13/28 (46.43%) |
66/137 (48.18%) |
63/149 (42.28%) |
13/37 (35.14%) |
8/37 (21.62%) |
19/37 (51.35%) |
61/131 (46.56%) |
57/119 (47.90%) |
Oedema Peripheral |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pyrexia (Solicited) |
15/348 (4.31%) |
0/347 (0.00%) |
3/120 (2.50%) |
4/126 (3.17%) |
0/28 (0.00%) |
0/28 (0.00%) |
2/28 (7.14%) |
5/137 (3.65%) |
12/149 (8.05%) |
0/37 (0.00%) |
0/37 (0.00%) |
4/37 (10.81%) |
8/131 (6.11%) |
7/119 (5.88%) |
Vaccination Site Erythema (Solicited) |
22/348 (6.32%) |
7/347 (2.02%) |
8/120 (6.67%) |
4/126 (3.17%) |
0/28 (0.00%) |
1/28 (3.57%) |
4/28 (14.29%) |
11/137 (8.03%) |
6/149 (4.03%) |
1/37 (2.70%) |
2/37 (5.41%) |
4/37 (10.81%) |
18/131 (13.74%) |
7/119 (5.88%) |
Vaccination Site Pain (Solicited) |
120/348 (34.48%) |
24/347 (6.92%) |
37/120 (30.83%) |
29/126 (23.02%) |
9/28 (32.14%) |
11/28 (39.29%) |
18/28 (64.29%) |
93/137 (67.88%) |
81/149 (54.36%) |
26/37 (70.27%) |
16/37 (43.24%) |
29/37 (78.38%) |
91/131 (69.47%) |
64/119 (53.78%) |
Vaccination Site Swelling (Solicited) |
12/348 (3.45%) |
6/347 (1.73%) |
8/120 (6.67%) |
4/126 (3.17%) |
0/28 (0.00%) |
1/28 (3.57%) |
3/28 (10.71%) |
10/137 (7.30%) |
8/149 (5.37%) |
0/37 (0.00%) |
3/37 (8.11%) |
4/37 (10.81%) |
17/131 (12.98%) |
4/119 (3.36%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Candida Infection |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Covid-19 |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
1/37 (2.70%) |
2/131 (1.53%) |
0/119 (0.00%) |
Cystitis |
1/348 (0.29%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/131 (0.00%) |
0/119 (0.00%) |
Oral Candidiasis |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Respiratory Tract Infection |
13/348 (3.74%) |
14/347 (4.03%) |
3/120 (2.50%) |
2/126 (1.59%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Tooth Infection |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Upper Respiratory Tract Infection |
8/348 (2.30%) |
10/347 (2.88%) |
0/120 (0.00%) |
1/126 (0.79%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Urinary Tract Infection |
2/348 (0.57%) |
4/347 (1.15%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/131 (0.00%) |
1/119 (0.84%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contusion |
2/348 (0.57%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Thermal Burn |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Upper Limb Fracture |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Heart Rate Irregular |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperglycaemia |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypokalaemia |
0/348 (0.00%) |
1/347 (0.29%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Hypomagnesaemia |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia |
2/348 (0.57%) |
0/347 (0.00%) |
1/120 (0.83%) |
2/126 (1.59%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
1/137 (0.73%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/131 (0.76%) |
0/119 (0.00%) |
Myalgia (Solicited) |
95/348 (27.30%) |
30/347 (8.65%) |
18/120 (15.00%) |
24/126 (19.05%) |
5/28 (17.86%) |
4/28 (14.29%) |
9/28 (32.14%) |
38/137 (27.74%) |
51/149 (34.23%) |
10/37 (27.03%) |
3/37 (8.11%) |
14/37 (37.84%) |
40/131 (30.53%) |
32/119 (26.89%) |
Osteoarthritis |
0/348 (0.00%) |
1/347 (0.29%) |
0/120 (0.00%) |
0/126 (0.00%) |
2/28 (7.14%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Pain in Extremity |
1/348 (0.29%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
1/119 (0.84%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basal Cell Carcinoma |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetic Neuropathy |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Headache |
2/348 (0.57%) |
5/347 (1.44%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Headache (Solicited) |
83/348 (23.85%) |
30/347 (8.65%) |
21/120 (17.50%) |
19/126 (15.08%) |
4/28 (14.29%) |
4/28 (14.29%) |
10/28 (35.71%) |
40/137 (29.20%) |
47/149 (31.54%) |
10/37 (27.03%) |
5/37 (13.51%) |
7/37 (18.92%) |
42/131 (32.06%) |
40/119 (33.61%) |
Radicular Pain |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Sciatica |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasal Polyps |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Sleep Apnoea Syndrome |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis |
1/348 (0.29%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
1/28 (3.57%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/131 (0.00%) |
0/119 (0.00%) |
Surgical and medical procedures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth Extraction |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/28 (0.00%) |
0/137 (0.00%) |
0/149 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/37 (2.70%) |
0/131 (0.00%) |
0/119 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension |
0/348 (0.00%) |
0/347 (0.00%) |
0/120 (0.00%) |
0/126 (0.00%) |
0/28 (0.00%) |
3/28 (10.71%) |
0/28 (0.00%) |
0/137 (0.00%) |
1/149 (0.67%) |
0/37 (0.00%) |
0/37 (0.00%) |
0/37 (0.00%) |
1/131 (0.76%) |
0/119 (0.00%) |
Term from vocabulary, MedDRA Version 25.1
Indicates events were collected by non-systematic assessment
|