Trial Outcomes & Findings for Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NCT NCT00428948)
NCT ID: NCT00428948
Last Updated: 2017-07-02
Results Overview
Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1445 participants
Primary outcome timeframe
Baseline to Month 36
Results posted on
2017-07-02
Participant Flow
Intent-to-treat population: All randomized participants.
Participant milestones
| Measure |
Tolvaptan
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Overall Study
STARTED
|
961
|
484
|
|
Overall Study
Received Treatment
|
961
|
483
|
|
Overall Study
COMPLETED
|
740
|
417
|
|
Overall Study
NOT COMPLETED
|
221
|
67
|
Reasons for withdrawal
| Measure |
Tolvaptan
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
8
|
|
Overall Study
Adverse Event
|
148
|
24
|
|
Overall Study
Subject Met Withdrawal Criteria
|
4
|
0
|
|
Overall Study
Investigator Withdrew Subject
|
3
|
4
|
|
Overall Study
Subject Withdrew Consent
|
50
|
30
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
Baseline Characteristics
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Baseline characteristics by cohort
| Measure |
Tolvaptan
n=961 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=484 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
Total
n=1445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
466 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
699 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
495 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
746 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 36Population: Intent-to-treat population: All randomized participants who had Baseline and post-baseline observations of total kidney volume. Only participants with available data were included in the analysis.
Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.
Outcome measures
| Measure |
Tolvaptan
n=819 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=458 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
|
2.777 Percentage change per year
Standard Deviation 5.659
|
5.608 Percentage change per year
Standard Deviation 5.330
|
SECONDARY outcome
Timeframe: Baseline to Month 36Population: Intent-to-treat population: All randomized participants. Only participants with available data were included in the analysis.
These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis. Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD. The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have \> 139 mmHg systolic blood pressure \[BP\], \> 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline. Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol). Categories included normal (\< 2.8 female or \< 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (\> 28 female or \> 20 male.
Outcome measures
| Measure |
Tolvaptan
n=961 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=483 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
|
43.94 Events/100 follow-up years
|
50.04 Events/100 follow-up years
|
SECONDARY outcome
Timeframe: Week 3 to Month 36Population: Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.
Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine. The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL). The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.
Outcome measures
| Measure |
Tolvaptan
n=842 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=464 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Change in Renal Function Per Year From Week 3 to Month 36
|
-2.555 (mg/mL)^-1 per year
Standard Deviation 9.767
|
-3.682 (mg/mL)^-1 per year
Standard Deviation 6.361
|
SECONDARY outcome
Timeframe: Baseline to Month 36Population: Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.
For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason. The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.
Outcome measures
| Measure |
Tolvaptan
n=129 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=74 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
|
2.561 mmHg
Standard Deviation 9.798
|
2.592 mmHg
Standard Deviation 7.095
|
SECONDARY outcome
Timeframe: At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2Population: Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.
Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives \[eg, tricyclic antidepressants\]) or surgical therapy for pain. In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain. A negative change score indicates less pain. AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.
Outcome measures
| Measure |
Tolvaptan
n=926 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=467 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
|
-0.00 units on a scale
Standard Deviation 1.29
|
0.08 units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline to Month 36Population: Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.
A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP \[sBP\] \> 129 mmHg and/or diastolic BP \[dBP\] \> 84 mmHg), (2) hypertensive (sBP \> 139 mmHg and/or dBP \> 89 mmHg), or (3) requiring antihypertensive therapy.
Outcome measures
| Measure |
Tolvaptan
n=174 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=79 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
|
31.80 Events/100 follow-up years
|
29.60 Events/100 follow-up years
|
SECONDARY outcome
Timeframe: Baseline to Month 36Population: Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants taking antihypertensive medication at Baseline with available data were included in the analysis.
Outcome measures
| Measure |
Tolvaptan
n=481 Participants
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=267 Participants
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36
|
6.24 Percentage of participants
|
5.62 Percentage of participants
|
Adverse Events
Tolvaptan
Serious events: 177 serious events
Other events: 793 other events
Deaths: 0 deaths
Placebo
Serious events: 95 serious events
Other events: 372 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tolvaptan
n=961 participants at risk
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=483 participants at risk
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Palpitations
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Pericarditis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Congenital, familial and genetic disorders
Multiple endocrine adenomatosis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Congenital, familial and genetic disorders
Deafness
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Eye disorders
Glaucoma
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Eye disorders
Retinal detachment
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Eye disorders
Uveitis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Anal fistula
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Periodontitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Chest pain
|
0.83%
8/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Exercise tolerance decreased
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Fatigue
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Thirst
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Immune system disorders
Anaphylactic shock
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Abscess limb
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.83%
4/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Arthritis bacterial
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Bartholin's abscess
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Cellulitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Diverticulitis
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Hepatic cyst infection
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Hepatitis B
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Kidney infection
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Liver abscess
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Malaria
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Mycoplasma infection
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Perineal abscess
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Pneumonia
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.52%
5/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
1.0%
5/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Renal cyst infection
|
0.62%
6/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.83%
4/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Syphilis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.62%
3/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Urogenital infection bacterial
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Varicella
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Viral infection
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Induced abortion haemorrhage
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.94%
9/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.94%
9/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Blood bilirubin increased
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Lipase increased
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Liver function test abnormal
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Transaminases increased
|
0.42%
4/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Ligament pain
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Headache
|
0.52%
5/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Loss of consciousness
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Migraine with aura
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Nerve root compression
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Parkinsonism
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Presyncope
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Sciatica
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Syncope
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Psychiatric disorders
Depression
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Psychiatric disorders
Major depression
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Psychiatric disorders
Suicide attempt
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.42%
4/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.62%
3/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Polyuria
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal cyst
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.83%
4/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal pain
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.83%
4/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.41%
2/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Asthenospermia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Hysterocele
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
2/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Haematoma
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Hypertension
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.62%
3/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Hypotension
|
0.31%
3/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.21%
1/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Varicose vein
|
0.10%
1/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
0.00%
0/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
Other adverse events
| Measure |
Tolvaptan
n=961 participants at risk
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
|
Placebo
n=483 participants at risk
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
|
|---|---|---|
|
Renal and urinary disorders
Pollakiuria
|
23.1%
222/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
5.4%
26/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Renal pain
|
27.7%
266/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
35.6%
172/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
78/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
7.9%
38/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
50/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
3.7%
18/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
49/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
1.9%
9/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Vascular disorders
Hypertension
|
33.7%
324/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
36.9%
178/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Polyuria
|
38.4%
369/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
17.2%
83/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
30/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
5.4%
26/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
49/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
3.5%
17/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
63/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
6.6%
32/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
63/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
8.9%
43/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
8.4%
81/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
2.5%
12/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
133/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
11.2%
54/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
16.0%
154/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
12.4%
60/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
78/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
3.3%
16/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
101/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
12.2%
59/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
8.4%
81/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
8.3%
40/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Asthenia
|
6.0%
58/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
5.6%
27/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Fatigue
|
13.7%
132/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
9.7%
47/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Oedema peripheral
|
9.2%
88/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
9.5%
46/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Pyrexia
|
4.7%
45/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
8.5%
41/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
General disorders
Thirst
|
55.4%
532/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
20.5%
99/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Bronchitis
|
6.1%
59/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
7.5%
36/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
55/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
4.6%
22/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Influenza
|
8.1%
78/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
7.9%
38/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
23.0%
221/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
23.0%
111/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Sinusitis
|
5.8%
56/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
4.8%
23/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
87/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
8.7%
42/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
87/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
13.5%
65/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Investigations
Blood creatinine increased
|
14.6%
140/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
14.7%
71/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.2%
69/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
1.0%
5/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Polydipsia
|
10.4%
100/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
3.5%
17/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
70/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
6.0%
29/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.4%
138/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
18.6%
90/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
52/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
3.5%
17/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
42/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
5.6%
27/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
11.2%
108/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
8.7%
42/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Nervous system disorders
Headache
|
25.3%
243/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
25.5%
123/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Psychiatric disorders
Insomnia
|
5.7%
55/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
4.8%
23/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Haematuria
|
7.4%
71/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
14.1%
68/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
|
Renal and urinary disorders
Nocturia
|
29.2%
281/961 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
13.0%
63/483 • Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Safety population: All randomized participants who received study treatment. One participant in the placebo group did not receive study treatment and was not included in the safety population.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place