Trial Outcomes & Findings for An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol (NCT NCT03060577)
NCT ID: NCT03060577
Last Updated: 2023-03-24
Results Overview
Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
382 participants
Primary outcome timeframe
Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total)
Results posted on
2023-03-24
Participant Flow
Participants were recruited from 51 sites in 5 countries.
After completion of study MDCO-PCS-15-01, participants were screened to fulfill all inclusion and exclusion criteria.
Participant milestones
| Measure |
Inclisiran-only
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
Switching
Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
|
|---|---|---|
|
Overall Study
STARTED
|
290
|
92
|
|
Overall Study
Safety Analysis Set
|
284
|
90
|
|
Overall Study
COMPLETED
|
233
|
80
|
|
Overall Study
NOT COMPLETED
|
57
|
12
|
Reasons for withdrawal
| Measure |
Inclisiran-only
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
Switching
Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
5
|
|
Overall Study
Physician Decision
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Death
|
7
|
1
|
|
Overall Study
Adverse Event
|
9
|
1
|
|
Overall Study
Inclusion/Exclusion
|
1
|
0
|
|
Overall Study
Other
|
8
|
2
|
Baseline Characteristics
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Baseline characteristics by cohort
| Measure |
Inclisiran-only
n=290 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
Switching
n=92 Participants
Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 Year
STANDARD_DEVIATION 11.14 • n=93 Participants
|
61.9 Year
STANDARD_DEVIATION 10.56 • n=4 Participants
|
63.0 Year
STANDARD_DEVIATION 11.01 • n=27 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
243 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
275 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total)Population: The overall number of participants analyzed includes all participants in the Safety Analysis Set of the Inclisiran-only arm with evaluable data for the endpoint.
Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm)
|
-47.48 Percentage Change
Interval -50.69 to -44.27
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-49.43 Percentage Change
Interval -52.27 to -46.58
|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 360
|
-37.14 Percentage Change
Interval -40.95 to -33.32
|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 720
|
-38.43 Percentage Change
Interval -41.75 to -35.11
|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1080
|
-51.07 Percentage Change
Interval -54.75 to -47.39
|
|
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-46.74 Percentage Change
Interval -50.71 to -42.78
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Absolute Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-62.51 mg/dL
Interval -66.76 to -58.25
|
|
Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 360
|
-47.96 mg/dL
Interval -52.56 to -43.35
|
|
Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 720
|
-49.44 mg/dL
Interval -54.25 to -44.64
|
|
Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1080
|
-63.34 mg/dL
Interval -68.76 to -57.92
|
|
Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-60.04 mg/dL
Interval -65.81 to -54.27
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Percent Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-71.80 Percentage Change
Interval -73.17 to -70.44
|
|
Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 360
|
-63.79 Percentage Change
Interval -65.79 to -61.8
|
|
Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 720
|
-62.17 Percentage Change
Interval -64.46 to -59.88
|
|
Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-69.54 Percentage Change
Interval -71.19 to -67.89
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Absolute Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-314.07 ug/L
Interval -328.69 to -299.45
|
|
Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 360
|
-280.88 ug/L
Interval -295.71 to -266.06
|
|
Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 720
|
-275.78 ug/L
Interval -291.91 to -259.64
|
|
Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-314.34 ug/L
Interval -331.22 to -297.46
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Percent Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-1.71 Percentage Change
Interval -6.42 to 3.0
|
|
Percentage Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
-3.35 Percentage Change
Interval -9.12 to 2.41
|
|
Percentage Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
0.73 Percentage Change
Interval -8.23 to 9.69
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Absolute Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Absolute Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-14.61 mg/dL
Interval -22.15 to -7.08
|
|
Absolute Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
-11.96 mg/dL
Interval -23.78 to -0.14
|
|
Absolute Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-14.83 mg/dL
Interval -25.75 to -3.9
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Percent Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-40.43 Percentage Change
Interval -42.57 to -38.29
|
|
Percentage Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
-36.65 Percentage Change
Interval -39.06 to -34.23
|
|
Percentage Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-33.66 Percentage Change
Interval -37.18 to -30.15
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Absolute Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Absolute Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-42.63 mg/dL
Interval -45.22 to -40.04
|
|
Absolute Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
-38.36 mg/dL
Interval -41.19 to -35.54
|
|
Absolute Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-36.26 mg/dL
Interval -40.01 to -32.52
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Percent Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Percentage Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-15.88 Percentage Change
Interval -19.48 to -12.28
|
|
Percentage Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
9.29 Percentage Change
Interval 4.42 to 14.16
|
|
Percentage Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-5.24 Percentage Change
Interval -9.86 to -0.61
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.
Absolute Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=277 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Absolute Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
-8.52 nmol/L
Interval -12.25 to -4.79
|
|
Absolute Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 210
|
-4.94 nmol/L
Interval -8.67 to -1.2
|
|
Absolute Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
-4.78 nmol/L
Interval -9.63 to 0.06
|
SECONDARY outcome
Timeframe: Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)Population: The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm. The number analyzed per row represents participants with evaluable data at each time point.
Number of Participants with ≥50% LDL-C (beta-quantification) Reduction from baseline of the ORION-1 Study overtime in ORION-3. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Outcome measures
| Measure |
Inclisiran-only
n=284 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 30
|
161 Participants
|
|
Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 360
|
99 Participants
|
|
Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 720
|
97 Participants
|
|
Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)
Day 1440
|
122 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment in ORION-3 to 90 days after end of treatment, assessed up to maximum duration of 4 yearsPopulation: The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm.
Individual responsiveness to inclisiran is defined as the number of Participants Reaching on Treatment LDL-C Levels of \<25 mg/dL, \<50 mg/dL, \<70 mg/dL, and \<100 mg/dL at any time point.
Outcome measures
| Measure |
Inclisiran-only
n=284 Participants
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
|---|---|
|
Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)
LDL-C level <25 mg/dL
|
82 Participants
|
|
Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)
LDL-C level <50 mg/dL
|
175 Participants
|
|
Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)
LDL-C level <70 mg/dL
|
225 Participants
|
|
Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)
LDL-C level <100 mg/dL
|
265 Participants
|
Adverse Events
Inclisiran Only Arm
Serious events: 104 serious events
Other events: 271 other events
Deaths: 7 deaths
Switching Arm up to Day 360 Visit
Serious events: 16 serious events
Other events: 78 other events
Deaths: 0 deaths
Switching Arm After Day 360 Visit
Serious events: 30 serious events
Other events: 77 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Inclisiran Only Arm
n=284 participants at risk
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
Switching Arm up to Day 360 Visit
n=90 participants at risk
Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336.
|
Switching Arm After Day 360 Visit
n=87 participants at risk
Participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Angina pectoris
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Angina unstable
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial flutter
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial tachycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Bradycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Cardiac failure
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Ileus
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Chest pain
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
General physical health deterioration
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Vascular stent restenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Appendicitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Bacterial infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
COVID-19
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Cellulitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Diverticulitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Escherichia sepsis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Gastrointestinal infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Infected bite
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Localised infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pneumonia
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Tooth abscess
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Urosepsis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication cardiac
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Pulse abnormal
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease stage IV
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular seminoma (pure) stage I
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Encephalopathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Ischaemic stroke
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Nervous system disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Presyncope
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Sciatica
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Syncope
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Delirium
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Urethral perforation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic aneurysm
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Circulatory collapse
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Intermittent claudication
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
Other adverse events
| Measure |
Inclisiran Only Arm
n=284 participants at risk
Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
|
Switching Arm up to Day 360 Visit
n=90 participants at risk
Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336.
|
Switching Arm After Day 360 Visit
n=87 participants at risk
Participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
|
|---|---|---|---|
|
Infections and infestations
Abscess of eyelid
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Acarodermatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Acute sinusitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.4%
4/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Angina pectoris
|
6.0%
17/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.4%
4/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Aortic valve incompetence
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial flutter
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrial thrombosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Bradycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Bundle branch block left
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Bundle branch block right
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Cardiac failure
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery aneurysm
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Dilatation atrial
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Palpitations
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Right ventricular dilatation
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Tachycardia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
9/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Endocrine disorders
Goitre
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Endocrine disorders
Hyperthyroidism
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Endocrine disorders
Thyroid mass
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Blepharitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Cataract
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Chalazion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Corneal erosion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Dacryostenosis acquired
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Diplopia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Dry eye
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Entropion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Epiretinal membrane
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Eye swelling
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Glaucoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Iritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Lacrimal mucocoele
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Lacrimation decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Macular degeneration
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Macular hole
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Meibomianitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Metamorphopsia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Ocular hypertension
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Photophobia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Retinal artery embolism
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Retinal haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Vision blurred
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Visual impairment
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Vitreous detachment
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Eye disorders
Vitreous floaters
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
13/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.4%
4/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Buccal polyp
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.6%
5/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Dental caries
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
17/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
10.3%
9/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Diverticulum
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Enteritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Flatulence
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Food poisoning
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal scarring
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Haematochezia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.2%
9/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Levator syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Melaena
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
18/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Pancreatic steatosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Adverse drug reaction
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Asthenia
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Chest discomfort
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Chest pain
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Chills
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Complication of device insertion
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Crepitations
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Cyst
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Discomfort
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Drug intolerance
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Face oedema
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Fatigue
|
8.1%
23/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
11.5%
10/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Feeling abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Gait disturbance
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Hernia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Influenza like illness
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site bruising
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.4%
4/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site discolouration
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site erythema
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site haematoma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site haemorrhage
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site oedema
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site pain
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site pruritus
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site rash
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site reaction
|
5.6%
16/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site urticaria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site vesicles
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Injection site warmth
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Malaise
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Medical device complication
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Nodule
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Non-cardiac chest pain
|
4.6%
13/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Oedema peripheral
|
3.9%
11/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Pain
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Peripheral swelling
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Polyp
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Pyrexia
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Vessel puncture site bruise
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
General disorders
Vessel puncture site induration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Drug hypersensitivity
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Food allergy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Hypersensitivity
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Mite allergy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Rubber sensitivity
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Immune system disorders
Seasonal allergy
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Abscess
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Bacterial infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Bacteriuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Balanitis candida
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Bronchitis
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
COVID-19
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Candida infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Cellulitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Clostridium difficile infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Corneal infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Coronavirus infection
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Cystitis
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Diarrhoea infectious
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Diverticulitis
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Ear infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Ear lobe infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
External ear cellulitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Eye infection
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Fungal infection
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Fungal skin infection
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Furuncle
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Gastroenteritis viral
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Genital herpes simplex
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Genital infection fungal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Herpes simplex
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Herpes zoster
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Hordeolum
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Impetigo
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Influenza
|
12.7%
36/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.7%
6/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
11.5%
10/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Kidney infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Klebsiella infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Labyrinthitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Localised infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.9%
11/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Mastitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Nail infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Nasopharyngitis
|
19.4%
55/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.7%
6/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
14.9%
13/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Onychomycosis
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Oral candidiasis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Oral fungal infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Oral herpes
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Oral infection
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Orchitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Otitis externa
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Otitis media
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Paronychia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Perichondritis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pharyngitis
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pneumonia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pneumonia viral
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Postoperative wound infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pulpitis dental
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Rash pustular
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Respiratory tract infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Retinitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Rhinitis
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Root canal infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Sebaceous gland infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Sinusitis
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Skin infection
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Staphylococcal infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Suspected COVID-19
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Tooth abscess
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Tooth infection
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
24/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Urethritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Urinary tract infection
|
13.0%
37/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.7%
6/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
8.0%
7/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Vaginal infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Viral diarrhoea
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Viral infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Infections and infestations
Wound infection
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
8.5%
24/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.3%
3/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Product dispensing error
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Reactive gastropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Wound
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Injury, poisoning and procedural complications
Wrong dose
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood bilirubin increased
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood calcium increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood creatinine increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood folate decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood glucose abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood glucose increased
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood potassium increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood pressure increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood sodium decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood urea increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood uric acid decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Blood urine present
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Body temperature increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
C-reactive protein increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Cardiac murmur
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Carotid bruit
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Electrocardiogram abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Glomerular filtration rate decreased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Haematocrit decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Haemoglobin decreased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Heart rate decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Heart rate irregular
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Hepatic enzyme increased
|
3.2%
9/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
International normalised ratio increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Lipoprotein (a) increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Lipoprotein increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Liver function test abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Liver function test increased
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Neutrophil count increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Platelet count decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Platelet count increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Prostatic specific antigen increased
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Pulse absent
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
QRS axis abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
SARS-CoV-2 test positive
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Sinus rhythm
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Spirometry abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Streptococcus test positive
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Thyroid function test abnormal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Troponin T increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Urine analysis abnormal
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Vitamin B12 decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Vitamin D decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Weight decreased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
Weight increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Investigations
White blood cell count increased
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.3%
32/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Gout
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.1%
40/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
11.1%
10/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
11.5%
10/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
28/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
14.9%
13/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone atrophy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.2%
9/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Exostosis of jaw
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
15/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.7%
6/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.5%
24/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
7.8%
7/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.6%
16/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
25/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
6.9%
6/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Shoulder deformity
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.9%
11/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Ageusia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Amnesia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Anosmia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Balance disorder
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Burning sensation
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cerebral infarction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cluster headache
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cognitive disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Diabetic neuropathy
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Dizziness
|
8.5%
24/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.4%
4/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Dizziness postural
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Dysgeusia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Epilepsy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Head discomfort
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Headache
|
7.4%
21/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
8.9%
8/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
8.0%
7/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Loss of consciousness
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Memory impairment
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Migraine
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Muscle tension dysphonia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Nerve compression
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Parkinson's disease
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Parkinsonism
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Piriformis syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Polyneuropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Presyncope
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Restless legs syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Sciatica
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Sensory loss
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Somnolence
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Syncope
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Taste disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Tremor
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Nervous system disorders
Vascular dementia
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Product Issues
Device dislocation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Product Issues
Prosthetic cardiac valve failure
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Acute stress disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Agitation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Alcoholism
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Anxiety
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Anxiety disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Burnout syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Confusional state
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Depressed mood
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Depression
|
4.2%
12/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Disorientation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Emotional distress
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Fear
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Indifference
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Insomnia
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Panic attack
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Seasonal affective disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Psychiatric disorders
Stress
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Albuminuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Bladder cyst
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Calculus bladder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Dysuria
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Glycosuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Haematuria
|
3.2%
9/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Incontinence
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Leukocyturia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Micturition disorder
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Micturition urgency
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Myoglobinuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Nephropathy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Pollakiuria
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Polyuria
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Renal colic
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Renal cyst
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Ureteral disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Breast disorder female
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Genital rash
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Spermatocele
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Vaginal dysplasia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
4.6%
4/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
7/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
22/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
22/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
5.7%
5/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.5%
10/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
8/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary calcification
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Actinic elastosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
4/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
11/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
3.4%
3/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.8%
5/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
11/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Surgical and medical procedures
Abortion induced
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic aneurysm
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.3%
2/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic dilatation
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Aortic stenosis
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Circulatory collapse
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Extremity necrosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Flushing
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hot flush
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hypertension
|
14.8%
42/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
2.2%
2/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
19.5%
17/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hypertensive urgency
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Hypotension
|
2.1%
6/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Intermittent claudication
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Lymphoedema
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Orthostatic hypotension
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.1%
3/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
1.1%
1/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Peripheral coldness
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Peripheral venous disease
|
0.70%
2/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Thrombosis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Varicophlebitis
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
|
Vascular disorders
Varicose vein
|
0.35%
1/284 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/90 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
0.00%
0/87 • Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER