Trial Outcomes & Findings for Safety and Clinical Performance of the Protecta ICD and CRT-D (NCT NCT00982397)
NCT ID: NCT00982397
Last Updated: 2017-11-06
Results Overview
Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2770 participants
Primary outcome timeframe
Implant to one year post-implant
Results posted on
2017-11-06
Participant Flow
Twenty patients were excluded from analysis, because they did not meet the eligibility criteria; 1 patient did not sign consent, 1 patient participated in a confounding trial, 8 patients did not have an implant attempted, 5 patients failed implant, and 5 patients received a device other than the Protecta.Total enrolled=2790, total analyzed=2770
Participant milestones
| Measure |
DR-ICD/CRT-D
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Phase I
STARTED
|
236
|
0
|
|
Phase I
COMPLETED
|
236
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
|
Phase II/Overall Study
STARTED
|
2019
|
751
|
|
Phase II/Overall Study
Secondary Prevention Randomized 18/24NID
|
231
|
122
|
|
Phase II/Overall Study
Secondary Prevention Randomized 30/40NID
|
221
|
131
|
|
Phase II/Overall Study
COMPLETED
|
2019
|
751
|
|
Phase II/Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Clinical Performance of the Protecta ICD and CRT-D
Baseline characteristics by cohort
| Measure |
DR-ICD/CRT-D
n=2019 Participants
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
n=751 Participants
Patients implanted with a single-chamber ICD (VR-ICD).
|
Total
n=2770 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
430 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1589 Participants
n=5 Participants
|
611 Participants
n=7 Participants
|
2200 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
44 participants
n=5 Participants
|
14 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
119 participants
n=5 Participants
|
145 participants
n=7 Participants
|
264 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
60 participants
n=5 Participants
|
42 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
248 participants
n=5 Participants
|
57 participants
n=7 Participants
|
305 participants
n=5 Participants
|
|
Region of Enrollment
India
|
7 participants
n=5 Participants
|
18 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
104 participants
n=5 Participants
|
58 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
61 participants
n=5 Participants
|
11 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
144 participants
n=5 Participants
|
37 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
17 participants
n=5 Participants
|
2 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
154 participants
n=5 Participants
|
86 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
121 participants
n=5 Participants
|
43 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
7 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
17 participants
n=5 Participants
|
3 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
13 participants
n=5 Participants
|
0 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United Arab Emirates
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
103 participants
n=5 Participants
|
11 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
709 participants
n=5 Participants
|
156 participants
n=7 Participants
|
865 participants
n=5 Participants
|
|
LVEF
|
31.8 %
STANDARD_DEVIATION 13.0 • n=5 Participants
|
33.3 %
STANDARD_DEVIATION 13.5 • n=7 Participants
|
32.2 %
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
QRS
|
133.7 ms
STANDARD_DEVIATION 33.7 • n=5 Participants
|
107.1 ms
STANDARD_DEVIATION 21.9 • n=7 Participants
|
125.9 ms
STANDARD_DEVIATION 33.0 • n=5 Participants
|
|
Indication
Secondary Prevention
|
593 participants
n=5 Participants
|
254 participants
n=7 Participants
|
847 participants
n=5 Participants
|
|
Indication
Primary Prevention
|
1426 participants
n=5 Participants
|
497 participants
n=7 Participants
|
1923 participants
n=5 Participants
|
|
Heart Failure Status
NYHA I
|
232 participants
n=5 Participants
|
187 participants
n=7 Participants
|
419 participants
n=5 Participants
|
|
Heart Failure Status
NYHA II
|
758 participants
n=5 Participants
|
346 participants
n=7 Participants
|
1104 participants
n=5 Participants
|
|
Heart Failure Status
NYHA III
|
754 participants
n=5 Participants
|
99 participants
n=7 Participants
|
853 participants
n=5 Participants
|
|
Heart Failure Status
NYHA IV
|
30 participants
n=5 Participants
|
8 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Heart Failure Status
No Heart Failure
|
245 participants
n=5 Participants
|
109 participants
n=7 Participants
|
354 participants
n=5 Participants
|
|
Heart Failure Status
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant to one year post-implantPrimary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
Outcome measures
| Measure |
DR-ICD/CRT-D
n=2019 Participants
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
n=751 Participants
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Percentage of Subjects Who Are Inappropriate Shock Free
|
98.5 percentage of patients
Interval 97.9 to 99.0
|
97.5 percentage of patients
Interval 96.1 to 98.5
|
PRIMARY outcome
Timeframe: Implant to one month post-implantPopulation: Phase I subjects (a subset of the total number of subjects) implanted with a Protecta device with at least 30 days of follow-up or a USADE within the first 30 days post-implant are included in this analysis. One hundred subjects met the criteria above and are included in the analysis.
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Outcome measures
| Measure |
DR-ICD/CRT-D
n=100 Participants
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)
|
0 percentage of patients
Interval to 3.0
As specified in the protocol and analysis plan, only a one-sided 95% binomial upper confidence bound is used.
|
—
|
PRIMARY outcome
Timeframe: At implantPopulation: Of the 236 subjects implanted, 40 subjects / episodes were classified as not useable. In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Outcome measures
| Measure |
DR-ICD/CRT-D
n=196 Participants
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off
|
100 percentage of patients
Interval 98.1 to
As specified in the protocol and analysis plan, a one-side lower confidence bound was used.
|
—
|
SECONDARY outcome
Timeframe: Implant to one year post-implantPopulation: Includes randomized secondary prevention patients from Phase II.
Outcome measures
| Measure |
DR-ICD/CRT-D
n=353 Participants
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
n=352 Participants
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free
|
96 percentage of patients
|
96 percentage of patients
|
Adverse Events
DR-ICD/CRT-D
Serious events: 452 serious events
Other events: 0 other events
Deaths: 0 deaths
VR-ICD
Serious events: 125 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DR-ICD/CRT-D
n=2019 participants at risk
Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
|
VR-ICD
n=751 participants at risk
Patients implanted with a single-chamber ICD (VR-ICD).
|
|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Endocarditis
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Endocarditis bacterial
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Erysipelas
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Arthritis infective
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Bacteraemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Bronchitis
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
8/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Bronchitis viral
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
8/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Angina pectoris
|
0.94%
19/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.53%
4/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Angina unstable
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
33/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.53%
4/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Atrial flutter
|
0.50%
10/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Atrial tachycardia
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Bradycardia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac arrest
|
0.35%
7/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac failure
|
5.3%
108/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
3.9%
29/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiac perforation
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Coronary artery disease
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Extrasystoles
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Palpitations
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Pericarditis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Tachycardia
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Torsade de pointes
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.25%
5/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.25%
5/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
40/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
1.9%
14/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Eye disorders
Retinopathy proliferative
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Cellulitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Colitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Constipation
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Ileus
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Asthenia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Catheter site haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Chest pain
|
0.69%
14/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.53%
4/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Death
|
0.25%
5/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device battery issue
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device capturing issue
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device dislocation
|
1.6%
32/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device electrical impedance issue
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device extrusion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device failure
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device issue
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device lead damage
|
0.45%
9/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device lead issue
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device malfunction
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device misuse
|
0.40%
8/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device pacing issue
|
0.25%
5/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Device stimulation issue
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
General physical health deterioration
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Hypothermia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Impaired healing
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Implant site haematoma
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Implant site pain
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Multi-organ failure
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Oedema
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Oversensing
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Pyrexia
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
Undersensing
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Arthritis bacterial
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Gangrene
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Gastroenteritis
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Implant site abscess
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Implant site infection
|
0.45%
9/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.53%
4/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Infection
|
0.35%
7/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Orchitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Pleural infection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Pneumonia
|
1.0%
21/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.80%
6/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Post procedural infection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Sepsis
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Sinusitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
7/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Urosepsis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Infections and infestations
Wound infection
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Pocket erosion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Arteriogram coronary
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Blood creatinine increased
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Blood glucose increased
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Blood pressure abnormal
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Catheterisation cardiac
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Colonoscopy
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Investigation
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Investigations
Liver function test abnormal
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant non-resectable
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial meningioma malignant
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
8/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Convulsion
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Dementia
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Dizziness
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Epilepsy
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Hemiparesis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Hypokinesia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Hypotonia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Loss of consciousness
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Syncope
|
0.89%
18/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.25%
5/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Psychiatric disorders
Alcohol abuse
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Psychiatric disorders
Anxiety
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Haematuria
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Nephritis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Nephropathy
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Renal and urinary disorders
Renal infarct
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Reproductive system and breast disorders
Rectocele
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Brain hypoxia
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
8/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
17/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottis ulcer
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
6/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.40%
3/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Adrenalectomy
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Corneal transplant
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Gastrectomy
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Heart transplant
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
High frequency ablation
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Indwelling catheter management
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Medical device change
|
0.54%
11/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Neurostimulator implantation
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Radiotherapy
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Toe amputation
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Urethral repair
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Vertebra dislocation reduction
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Surgical and medical procedures
Vertebroplasty
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
General disorders
|
0.20%
4/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Aortic aneurysm
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Aortic stenosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Arterial occlusive disease
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Arteriovenous fistula
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Artery dissection
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Embolism arterial
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Haematoma
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Hypertension
|
0.15%
3/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Hypotension
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Hypovolaemic shock
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Iliac artery stenosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Leriche syndrome
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
10/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.27%
2/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Peripheral ischaemia
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Thrombophlebitis
|
0.10%
2/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Thrombosis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Vasculitis
|
0.05%
1/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.00%
0/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/2019 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
0.13%
1/751 • Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Other (non-serious) AE data were not collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PIs may not publish single-site data until the main multi-site publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER