Trial Outcomes & Findings for Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (NCT NCT01179048)
NCT ID: NCT01179048
Last Updated: 2019-07-17
Results Overview
Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9341 participants
Primary outcome timeframe
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Results posted on
2019-07-17
Participant Flow
410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).
All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial.
Participant milestones
| Measure |
Liraglutide
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Overall Study
STARTED
|
4668
|
4672
|
|
Overall Study
COMPLETED
|
4529
|
4513
|
|
Overall Study
NOT COMPLETED
|
139
|
159
|
Reasons for withdrawal
| Measure |
Liraglutide
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Overall Study
Withdrawn - does not allow contact
|
4
|
8
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
|
Overall Study
Alive
|
127
|
142
|
Baseline Characteristics
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Baseline characteristics by cohort
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Total
n=9340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Age, Customized
Between 18 and 64 years
|
2512 Participants
n=5 Participants
|
2499 Participants
n=7 Participants
|
5011 Participants
n=5 Participants
|
|
Age, Customized
Between 65 to 84 years
|
2139 Participants
n=5 Participants
|
2148 Participants
n=7 Participants
|
4287 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1657 Participants
n=5 Participants
|
1680 Participants
n=7 Participants
|
3337 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3011 Participants
n=5 Participants
|
2992 Participants
n=7 Participants
|
6003 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All randomised subjects.
Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
|
13.0 percentage of subjects
|
14.9 percentage of subjects
|
SECONDARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All randomised subjects.
Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.
|
20.3 percentage of subjects
|
22.7 percentage of subjects
|
SECONDARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All randomised subjects
Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Randomisation to All Cause Death
|
8.2 percentage of subjects
|
9.6 percentage of subjects
|
SECONDARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All the randomised subjects.
Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Cardiovascular death
|
4.7 percentage of subjects
|
6.0 percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Non-fatal stroke
|
3.4 percentage of subjects
|
3.8 percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Non-fatal myocardial infarction
|
6.0 percentage of subjects
|
6.8 percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Unstable angina pectoris (hospitalisation)
|
2.6 percentage of subjects
|
2.7 percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Coronary revascularisation
|
8.7 percentage of subjects
|
9.4 percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Heart failure (hospitalisation)
|
4.7 percentage of subjects
|
5.3 percentage of subjects
|
SECONDARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All randomised subjects.
Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: * new onset of persistent macroalbuminuria * persistent doubling of serum creatinine * need for continuous renal replacement therapy * death due to renal disease * need for retinal photocoagulation or treatment with intravitreal agents * vitreous haemorrhage * diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Randomisation to First Occurrence of a Composite Microvascular Outcome
|
7.6 Percentage of subjects
|
8.9 Percentage of subjects
|
SECONDARY outcome
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)Population: All randomised subjects
Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.
Outcome measures
| Measure |
Liraglutide
n=4668 Participants
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 Participants
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Nephropathy composite
|
5.7 Percentage of subjects
|
7.2 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
New onset of persistent macroalbuminuria
|
3.4 Percentage of subjects
|
4.6 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Persistent doubling of serum creatinine
|
1.9 Percentage of subjects
|
2.1 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Need for continuous renal-replacement therapy
|
1.2 Percentage of subjects
|
1.4 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Death due to renal disease
|
0.2 Percentage of subjects
|
0.1 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Retinopathy composite
|
2.3 Percentage of subjects
|
2.0 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Treatment with photocoagulation/intravitreal agent
|
2.1 Percentage of subjects
|
1.8 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Development of diabetes-related blindness
|
0.0 Percentage of subjects
|
0.02 Percentage of subjects
|
|
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Vitreous haemorrhage
|
0.7 Percentage of subjects
|
0.5 Percentage of subjects
|
Adverse Events
Liraglutide
Serious events: 2320 serious events
Other events: 684 other events
Deaths: 0 deaths
Placebo
Serious events: 2354 serious events
Other events: 210 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide
n=4668 participants at risk
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 participants at risk
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage III
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.96%
45/4668 • Number of events 52 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.3%
63/4672 • Number of events 73 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Obesity
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Obesity surgery
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Oedema
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Oedema peripheral
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma stage IV
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Open angle glaucoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Optic nerve infarction
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Orchitis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage IV
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
75/4668 • Number of events 80 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.4%
64/4672 • Number of events 69 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Osteomyelitis
|
0.45%
21/4668 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.49%
23/4672 • Number of events 30 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Osteomyelitis acute
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Otitis externa
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Otitis media
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Otitis media chronic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholestasis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abdominal abscess
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
20/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Abdominal panniculectomy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abdominal wall abscess
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Abdominoplasty
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abscess limb
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abscess neck
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Abscess of salivary gland
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Accelerated hypertension
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Accident
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Acquired claw toe
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic elastosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.79%
37/4668 • Number of events 41 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.2%
54/4672 • Number of events 59 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Acute hepatitis B
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
108/4668 • Number of events 124 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.0%
94/4672 • Number of events 105 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.3%
155/4668 • Number of events 176 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
4.0%
187/4672 • Number of events 211 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.28%
13/4668 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.47%
22/4668 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.39%
18/4672 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Acute sinusitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.30%
14/4668 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Adhesion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Adverse drug reaction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Afferent loop syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Air embolism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Alcohol abuse
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Alcoholism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Amaurosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Ammonia increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Amylase increased
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
31/4668 • Number of events 32 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.45%
21/4672 • Number of events 22 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Anal abscess
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Anaphylactic reaction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Angina pectoris
|
2.0%
93/4668 • Number of events 105 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.0%
93/4672 • Number of events 106 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Angina unstable
|
3.1%
144/4668 • Number of events 179 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
3.2%
151/4672 • Number of events 180 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.13%
6/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Angiogram peripheral
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Angioplasty
|
0.15%
7/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Ankle operation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic aneurysm
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Aortic bypass
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic dissection
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic occlusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Aortic stenosis
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Aortic surgery
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Aortic valve calcification
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Aphakia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Appendicitis
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.21%
10/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Arterial repair
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Arterial therapeutic procedure
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Arteriosclerosis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.34%
16/4668 • Number of events 17 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Arthritis infective
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Asthenia
|
0.19%
9/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
12/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.30%
14/4672 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Ataxia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Atherectomy
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
89/4668 • Number of events 113 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.1%
97/4672 • Number of events 112 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.36%
17/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.34%
16/4672 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Atypical pneumonia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Aural polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Autoimmune uveitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Azotaemia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma low grade
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
14/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.43%
20/4672 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bacterial food poisoning
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bacterial sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.30%
14/4668 • Number of events 17 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.54%
25/4668 • Number of events 25 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.49%
23/4672 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary adenoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Biliary cirrhosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Biliary colic
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
3/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage III
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder dysplasia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder squamous cell carcinoma stage unspecified
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage III
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Blepharitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Blindness unilateral
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood alcohol increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood calcitonin increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood creatinine increased
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood glucose fluctuation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood glucose increased
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood iron decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood magnesium decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood potassium increased
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood pressure decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood pressure increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood urea increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Blood urine present
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Brain stem infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Breast mass
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bronchitis
|
0.32%
15/4668 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.51%
24/4672 • Number of events 25 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
0.24%
11/4668 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.41%
19/4672 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.04%
2/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Bundle branch block left
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Buried penis syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Calculus urinary
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Carbuncle
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.43%
20/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.66%
31/4672 • Number of events 31 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Cardiac death
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac discomfort
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac disorder
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac failure
|
2.5%
115/4668 • Number of events 138 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.9%
137/4672 • Number of events 201 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac failure acute
|
0.19%
9/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.60%
28/4668 • Number of events 28 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.54%
25/4672 • Number of events 29 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
121/4668 • Number of events 180 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.8%
129/4672 • Number of events 176 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Cardiac murmur
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiac pacemaker removal
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cardiac valve abscess
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Cardiac valve rupture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.32%
15/4668 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiopulmonary bypass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Cardiospasm
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Cardiovascular evaluation
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cardiovascular event prophylaxis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Carotid angioplasty
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Carotid artery bypass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.60%
28/4668 • Number of events 30 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.34%
16/4672 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.41%
19/4668 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.30%
14/4672 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Carotid revascularisation
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Cataract
|
0.51%
24/4668 • Number of events 29 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.68%
32/4672 • Number of events 35 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cataract operation
|
0.04%
2/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Catheter site haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Catheterisation cardiac
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Cell death
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cellulitis
|
0.79%
37/4668 • Number of events 50 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.2%
54/4672 • Number of events 61 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebellar haematoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
14/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.43%
20/4672 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cerebral revascularisation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
52/4668 • Number of events 56 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.4%
65/4672 • Number of events 68 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cervical myelopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cervicitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Chest discomfort
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Chest pain
|
1.1%
53/4668 • Number of events 56 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.0%
49/4672 • Number of events 52 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Chills
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.75%
35/4668 • Number of events 35 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.39%
18/4672 • Number of events 19 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cholecystitis infective
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.94%
44/4668 • Number of events 45 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.64%
30/4672 • Number of events 30 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cholera
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesterol granuloma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma metastatic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
52/4668 • Number of events 60 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.1%
52/4672 • Number of events 55 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 1
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
50/4668 • Number of events 68 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.3%
59/4672 • Number of events 82 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Chronic pigmented purpura
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Circulatory collapse
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Clostridium colitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Clostridium difficile infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Cognitive disorder
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.28%
13/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.34%
16/4672 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Colonoscopy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Colonoscopy normal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Colostomy closure
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Coma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Contrast media allergy
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.99%
46/4668 • Number of events 56 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.83%
39/4672 • Number of events 42 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
2.4%
110/4668 • Number of events 117 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.4%
112/4672 • Number of events 136 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Coronary artery bypass
|
1.8%
84/4668 • Number of events 86 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.2%
102/4672 • Number of events 105 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
73/4668 • Number of events 77 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.9%
87/4672 • Number of events 89 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.34%
16/4668 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
20/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.75%
35/4672 • Number of events 36 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Coronary revascularisation
|
2.6%
120/4668 • Number of events 144 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.8%
132/4672 • Number of events 157 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Culture urine positive
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Cushing's syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Cystitis
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Cystocele
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Death
|
1.2%
55/4668 • Number of events 55 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.0%
47/4672 • Number of events 47 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Decreased activity
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
20/4668 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
30/4668 • Number of events 30 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.47%
22/4672 • Number of events 22 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Delirium
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dementia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dependence on respirator
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Depression
|
0.19%
9/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Device battery issue
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Device dislocation
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Device leakage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Device malfunction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Device occlusion
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Device related infection
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Device related sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.54%
25/4668 • Number of events 28 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.92%
43/4672 • Number of events 47 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Diabetic blindness
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.4%
66/4668 • Number of events 88 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.7%
80/4672 • Number of events 94 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Diabetic foot infection
|
0.24%
11/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Diabetic gangrene
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.24%
11/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.19%
9/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Diabetic retinal oedema
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Diabetic retinopathy
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.02%
1/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
14/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Diarrhoea infectious
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Dilatation atrial
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Diplopia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Disorientation
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.15%
7/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dizziness
|
0.26%
12/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Drowning
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Drug hypersensitivity
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Drug interaction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Dry gangrene
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Duodenitis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dysarthria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Dysentery
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
20/4668 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.68%
32/4672 • Number of events 36 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Ear infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Ejection fraction decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Embolic stroke
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Endarterectomy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Endocarditis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Endophthalmitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Enterococcal infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Epididymitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Epididymitis ureaplasmal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Erysipelas
|
0.21%
10/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.30%
14/4672 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Extradural abscess
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Extrasystoles
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Extremity necrosis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Eye infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Eyelid ptosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Faecalith
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.06%
3/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
84/4668 • Number of events 94 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.7%
81/4672 • Number of events 83 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Fatigue
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Femoral artery occlusion
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Fibrillary glomerulonephritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III stage I
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III stage IV
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Gait disturbance
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gangrene
|
0.21%
10/4668 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Gastric banding
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Gastric bypass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage III
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.32%
15/4668 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastritis bacterial
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.71%
33/4668 • Number of events 34 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.66%
31/4672 • Number of events 31 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
14/4668 • Number of events 17 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.45%
21/4672 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.02%
1/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Gastroplasty
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
General physical health deterioration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Generalised oedema
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Giant cell tumour of tendon sheath
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Glaucoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Glomerular filtration rate decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Glomerulosclerosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glomus tumour
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Goitre
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
0.09%
4/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Granuloma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of spleen
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Haematoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Haematoma infection
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Hamartoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Headache
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Heart rate decreased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Heart rate increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Helicobacter gastritis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Helicobacter infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hemiplegia
|
0.02%
1/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatopulmonary syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Hernia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Human ehrlichiosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hyperaesthesia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Hypercorticoidism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.73%
34/4668 • Number of events 35 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.0%
49/4672 • Number of events 52 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.19%
9/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hyperosmolar hyperglycaemic state
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Hypertension
|
0.69%
32/4668 • Number of events 36 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.54%
25/4672 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
0.30%
14/4668 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Hypertensive emergency
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Hypoaldosteronism
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.94%
44/4668 • Number of events 60 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.6%
75/4672 • Number of events 92 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.45%
21/4668 • Number of events 24 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.60%
28/4672 • Number of events 28 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
7/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Hypotension
|
0.39%
18/4668 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.34%
16/4672 • Number of events 17 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Hypothermia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Ileal gangrene
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Imaging procedure
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Impaired healing
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Incarcerated hernia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Incarcerated hiatus hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Incision site infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infected bites
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infected dermal cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infectious colitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infectious pleural effusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
2/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Inflammation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Influenza
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.26%
12/4668 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.30%
14/4672 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Insulin-requiring type 2 diabetes mellitus
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Intermittent claudication
|
0.11%
5/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Internal carotid artery kinking
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Internal haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
International normalised ratio decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
International normalised ratio increased
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.28%
13/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.49%
23/4672 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Intervertebral discitis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Intracranial lipoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Iridocyclitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Iritis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Ischaemic heart disease prophylaxis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
50/4668 • Number of events 54 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.2%
54/4672 • Number of events 59 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Kidney infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Klebsiella sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Knee operation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Labile hypertension
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Lacunar infarction
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large granular lymphocytosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.34%
16/4668 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage I
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal dysplasia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Laryngitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Left ventricular end-diastolic pressure increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Left ventricular failure
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Legionella infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Lethargy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Lipase increased
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Liver abscess
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Liver function test abnormal
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Lividity
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Lobar pneumonia
|
0.32%
15/4668 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Local swelling
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Localised infection
|
0.15%
7/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Loss of consciousness
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.32%
15/4668 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.24%
11/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Lung infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage IV
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Lymphocele
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Lymphoedema
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Macular fibrosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Macular oedema
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Macular rupture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Malaise
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant glioma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Mania
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Mass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Mastitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Mastoiditis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Medical device battery replacement
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Medical device change
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Medical device complication
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Melanocytic hyperplasia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Meningitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Mental disorder
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Metaplasia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Microangiopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Mitral valve calcification
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous breast carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Mucosal inflammation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Multi-organ failure
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Multiple system atrophy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Myasthenia gravis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
68/4668 • Number of events 71 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.8%
84/4672 • Number of events 89 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.58%
27/4668 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.71%
33/4672 • Number of events 35 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.17%
8/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipoidica diabeticorum
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Necrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Necrosis ischaemic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Necrotising fasciitis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Nephritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
26/4668 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.45%
21/4672 • Number of events 22 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Nephropathy
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Neuritis cranial
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Neutropenic sepsis
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Pain
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Palpitations
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Pancreas divisum
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Pancreatic enzymes increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.02%
1/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
18/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
14/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.41%
19/4672 • Number of events 22 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Papilloedema
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Paraplegia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Parkinsonism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Parotitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Pelvic floor repair
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Penetrating atherosclerotic ulcer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Penile infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
1.3%
59/4668 • Number of events 71 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.2%
57/4672 • Number of events 66 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pericardial cyst
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pericarditis uraemic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Perichondritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.51%
24/4668 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.73%
34/4672 • Number of events 38 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.43%
20/4668 • Number of events 25 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.58%
27/4672 • Number of events 29 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.24%
11/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.30%
14/4672 • Number of events 19 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.17%
8/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 19 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Peripheral artery stent insertion
|
0.15%
7/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.28%
13/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.62%
29/4668 • Number of events 33 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.77%
36/4672 • Number of events 47 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.21%
10/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Peritonitis
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Peritonitis bacterial
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Personality disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Phlebitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Phlebosclerosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pilonidal cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 18 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia
|
2.8%
133/4668 • Number of events 154 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
3.0%
141/4672 • Number of events 157 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia influenzal
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pneumonia viral
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Pneumopericardium
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Polyneuropathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Post procedural cellulitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural hypothyroidism
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Post procedural infection
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Post procedural sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Post-traumatic headache
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Postoperative wound infection
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Presyncope
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Prophylaxis against dehydration
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.51%
24/4668 • Number of events 24 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.83%
39/4672 • Number of events 39 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Prostatic dysplasia
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Prostatic specific antigen increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
21/4668 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.51%
24/4672 • Number of events 26 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.36%
17/4668 • Number of events 22 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.45%
21/4672 • Number of events 25 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pulmonary sepsis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pyelonephritis
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pyelonephritis acute
|
0.13%
6/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Pyrexia
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Pyuria
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Reactive gastropathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Rectal abscess
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage II
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.13%
6/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Renal artery stent placement
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage II
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal colic
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal cyst
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.43%
20/4668 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.66%
31/4672 • Number of events 33 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Renal function test
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
14/4668 • Number of events 14 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal infarct
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal pain
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Renal revascularisation surgery
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
18/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.41%
19/4672 • Number of events 21 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Restless legs syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal aneurysm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal artery occlusion
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal degeneration
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal detachment
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal infarction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal vascular occlusion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal vein occlusion
|
0.06%
3/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinal vein thrombosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinopathy haemorrhagic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.43%
20/4668 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.34%
16/4672 • Number of events 16 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Salmonella sepsis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Salmonellosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Immune system disorders
Sarcoidosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Sciatica
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Scrotal abscess
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Seizure
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Sepsis
|
1.0%
48/4668 • Number of events 50 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.73%
34/4672 • Number of events 36 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Septic shock
|
0.17%
8/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.28%
13/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Serotonin syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Serum ferritin decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Shock
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Shock haemorrhagic
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Single functional kidney
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Sinus arrest
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.19%
9/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Skin graft
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.21%
10/4668 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.32%
15/4672 • Number of events 15 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
10/4668 • Number of events 12 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 23 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Soft tissue infection
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Somatisation disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Spinal claudication
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.15%
7/4668 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Spinal cord injury thoracic
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Spinal decompression
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.15%
7/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.09%
4/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Stent placement
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.11%
5/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Sudden cardiac death
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Sudden death
|
0.24%
11/4668 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.36%
17/4672 • Number of events 17 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Psychiatric disorders
Suicide attempt
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.19%
9/4668 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.15%
7/4672 • Number of events 9 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Syncope
|
0.84%
39/4668 • Number of events 43 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.56%
26/4672 • Number of events 27 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Testicular abscess
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Testicular necrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Thalamic infarction
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Thrombectomy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Thrombophlebitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.06%
3/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Thrombosis
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
General disorders
Thrombosis in device
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Thrombotic stroke
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Thyroid C-cell hyperplasia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Thyroiditis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tonsillitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
52/4668 • Number of events 57 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.5%
68/4672 • Number of events 73 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Transplant evaluation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.09%
4/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Troponin increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Tuberculosis of genitourinary system
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Ulcerative keratitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Ulnocarpal abutment syndrome
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Ureteral polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.26%
12/4672 • Number of events 13 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
47/4668 • Number of events 51 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
1.5%
71/4672 • Number of events 79 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Urosepsis
|
0.17%
8/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.36%
17/4672 • Number of events 19 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Vaginal abscess
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Varicose vein
|
0.02%
1/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Vascular dementia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Vascular graft
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 7 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.04%
2/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Vascular operation
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Vascular stent insertion
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Vasculitis necrotising
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.09%
4/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.13%
6/4672 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.39%
18/4668 • Number of events 29 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.17%
8/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.21%
10/4672 • Number of events 10 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.06%
3/4668 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Viral infection
|
0.11%
5/4668 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Viral myocarditis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Viral pharyngitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Viral sinusitis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Vision blurred
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Visual impairment
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Vitreous adhesions
|
0.04%
2/4668 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Eye disorders
Vitreous haemorrhage
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.11%
5/4672 • Number of events 5 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/4668 • Number of events 8 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
17/4668 • Number of events 20 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.24%
11/4672 • Number of events 11 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval neoplasm
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Social circumstances
Walking disability
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Weight decreased
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.06%
3/4672 • Number of events 3 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Investigations
Weight increased
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/4668 • Number of events 4 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.04%
2/4672 • Number of events 2 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Wound infection
|
0.13%
6/4668 • Number of events 6 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.02%
1/4668 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.00%
0/4672 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Infections and infestations
Zygomycosis
|
0.00%
0/4668 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
0.02%
1/4672 • Number of events 1 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
Other adverse events
| Measure |
Liraglutide
n=4668 participants at risk
Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
Placebo
n=4672 participants at risk
Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
266/4668 • Number of events 355 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.2%
102/4672 • Number of events 124 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
517/4668 • Number of events 655 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
2.8%
129/4672 • Number of events 149 • Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER