Trial Outcomes & Findings for Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction (NCT NCT02884206)
NCT ID: NCT02884206
Last Updated: 2024-08-06
Results Overview
The CogState cognitive battery was composed of 7 tests, which were administered electronically by the patients at scheduled visits. For each test, a standardized z-score was calculated. The GCCS was the average of the non-missing individual test z-scores. A higher score indicated better cognitive function. CogState GCCS changes from baseline (randomization) were analyzed using a repeated measures ANCOVA in which treatment, age stratification factor, Mini mental state examination stratification factor, education level, Apolipoprotein E ε4 allele status, cerebrovascular disease burden at screening, visit and treatment-by-visit interaction are included as fixed-effect factor, and baseline (randomization) GCCS and visit-by- baseline GCCS as covariates with a common unstructured covariance matrix among visits between treatment groups. The analysis was based on a direct likelihood method with an assumption of Missing at random.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
592 participants
Primary outcome timeframe
Baseline, month 36
Results posted on
2024-08-06
Participant Flow
The study was conducted in 137 centers across 20 countries
A total of 1200 patients were screened. Of them, 706 patients entered the run-in period. Patients entered different parts of the treatment run-in phase based on their use of renin angiotensin system blockade medications at the time of enrolment (valsartan 40 mg bid (if necessary), followed by valsartan 80 mg bid, and then followed by LCZ696 100 mg bid, over 3 to 8 weeks duration)
Participant milestones
| Measure |
Run-in Period
Treatment run-in consisted of valsartan 40 mg bid (if necessary), followed by valsartan 80 mg bid, and then followed by LCZ696 100 mg bid, over 3 to 8 weeks duration.
|
LCZ696 200 mg Bid
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|---|
|
Valsartan Run-in Period
STARTED
|
706
|
0
|
0
|
|
Valsartan Run-in Period
COMPLETED
|
659
|
0
|
0
|
|
Valsartan Run-in Period
NOT COMPLETED
|
47
|
0
|
0
|
|
LCZ696 Run-in Period
STARTED
|
659
|
0
|
0
|
|
LCZ696 Run-in Period
COMPLETED
|
592
|
0
|
0
|
|
LCZ696 Run-in Period
NOT COMPLETED
|
67
|
0
|
0
|
|
Double-Blind Period
STARTED
|
0
|
295
|
297
|
|
Double-Blind Period
Safety Set
|
0
|
295
|
297
|
|
Double-Blind Period
PET Substudy Set
|
0
|
244
|
247
|
|
Double-Blind Period
COMPLETED
|
0
|
251
|
237
|
|
Double-Blind Period
NOT COMPLETED
|
0
|
44
|
60
|
Reasons for withdrawal
| Measure |
Run-in Period
Treatment run-in consisted of valsartan 40 mg bid (if necessary), followed by valsartan 80 mg bid, and then followed by LCZ696 100 mg bid, over 3 to 8 weeks duration.
|
LCZ696 200 mg Bid
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|---|
|
Valsartan Run-in Period
Death
|
1
|
0
|
0
|
|
Valsartan Run-in Period
Adverse Event
|
31
|
0
|
0
|
|
Valsartan Run-in Period
Patient/guardian decision
|
9
|
0
|
0
|
|
Valsartan Run-in Period
Protocol deviation
|
4
|
0
|
0
|
|
Valsartan Run-in Period
Non-compliance with study treatment
|
1
|
0
|
0
|
|
Valsartan Run-in Period
Physician Decision
|
1
|
0
|
0
|
|
LCZ696 Run-in Period
Adverse Event
|
38
|
0
|
0
|
|
LCZ696 Run-in Period
Death
|
2
|
0
|
0
|
|
LCZ696 Run-in Period
Patient/guardian decision
|
16
|
0
|
0
|
|
LCZ696 Run-in Period
Protocol deviation
|
6
|
0
|
0
|
|
LCZ696 Run-in Period
Non-compliance with study treatment
|
3
|
0
|
0
|
|
LCZ696 Run-in Period
Physician Decision
|
1
|
0
|
0
|
|
LCZ696 Run-in Period
Lost to Follow-up
|
1
|
0
|
0
|
|
Double-Blind Period
Death
|
0
|
28
|
39
|
|
Double-Blind Period
Patient/guardian decision
|
0
|
10
|
13
|
|
Double-Blind Period
Lost to Follow-up
|
0
|
4
|
4
|
|
Double-Blind Period
Physician Decision
|
0
|
2
|
0
|
|
Double-Blind Period
Adverse Event
|
0
|
0
|
3
|
|
Double-Blind Period
Non-compliance with study treatment
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
Baseline characteristics by cohort
| Measure |
LCZ696 200 mg Bid
n=295 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=297 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
Total
n=592 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.27 years
STANDARD_DEVIATION 6.749 • n=5 Participants
|
72.61 years
STANDARD_DEVIATION 7.043 • n=7 Participants
|
72.44 years
STANDARD_DEVIATION 6.895 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
273 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
544 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 36Population: The overall number of participants analyzed represents the participants in the Safety Set (SAF) with non-missing value of CogState GCCS at both, baseline and month 36. The SAF comprised all randomized patients who received at least one dose of study drug.
The CogState cognitive battery was composed of 7 tests, which were administered electronically by the patients at scheduled visits. For each test, a standardized z-score was calculated. The GCCS was the average of the non-missing individual test z-scores. A higher score indicated better cognitive function. CogState GCCS changes from baseline (randomization) were analyzed using a repeated measures ANCOVA in which treatment, age stratification factor, Mini mental state examination stratification factor, education level, Apolipoprotein E ε4 allele status, cerebrovascular disease burden at screening, visit and treatment-by-visit interaction are included as fixed-effect factor, and baseline (randomization) GCCS and visit-by- baseline GCCS as covariates with a common unstructured covariance matrix among visits between treatment groups. The analysis was based on a direct likelihood method with an assumption of Missing at random.
Outcome measures
| Measure |
LCZ696 200 mg Bid
n=195 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=183 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|
|
Change From Baseline in the CogState Global Cognitive Composite Score (GCCS)
|
-0.0902 Global Cognitive Composite Score
Standard Error 0.0372
|
-0.0722 Global Cognitive Composite Score
Standard Error 0.0383
|
SECONDARY outcome
Timeframe: Baseline, month 36Population: The overall number of participants analyzed represents the participants in the PET substudy set (PET) with non-missing value at both, baseline and month 36. The PET comprised SAF patients who participated in PET substudy and had non-missing baseline assessment.
The effects of LCZ696 compared to valsartan on Aβ deposition in the brain over 3 years were evaluated in a subset of patients using amyloid positron emission tomography (PET) imaging by assessing the change from baseline in cortical composite SUVr. PET imaging was performed at selected PET-capable centers on all eligible patients participating in the substudy. Sites with patients performing the PET scan were a subset of the overall patient population and overall sites for the study. Change from baseline to 3 years was analyzed based on an ANCOVA model with treatment, age, MMSE, amyloid status (+ve/-ve) stratification factors, region, APOE4 status and cerebrovascular disease burden as fixed effects, with baseline SUVr and treatment-by-baseline SUVr interaction as covariates for each of these imputed datasets. Results were obtained by applying Rubin's rules on the estimates from the imputed datasets.
Outcome measures
| Measure |
LCZ696 200 mg Bid
n=147 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=134 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Global cortical composite
|
0.0273 value ratio (SUVr)
Standard Error 0.0114
|
0.0564 value ratio (SUVr)
Standard Error 0.0101
|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Cingulum posterior composite
|
0.0416 value ratio (SUVr)
Standard Error 0.0113
|
0.0876 value ratio (SUVr)
Standard Error 0.0109
|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Frontal lobe composite
|
0.0218 value ratio (SUVr)
Standard Error 0.0117
|
0.0434 value ratio (SUVr)
Standard Error 0.0104
|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Parietal lobe composite
|
0.0231 value ratio (SUVr)
Standard Error 0.0119
|
0.0532 value ratio (SUVr)
Standard Error 0.0104
|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Temporal lobe composite
|
0.0249 value ratio (SUVr)
Standard Error 0.0110
|
0.0418 value ratio (SUVr)
Standard Error 0.0097
|
|
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
White matter composite
|
0.0061 value ratio (SUVr)
Standard Error 0.0094
|
-0.0072 value ratio (SUVr)
Standard Error 0.0083
|
SECONDARY outcome
Timeframe: Baseline, month 36Population: The overall number of participants analyzed represents the participants in the Safety Set (SAF) with non-missing value at both, baseline and month 36. The number analyzed per row represents the participants with a valid value for the corresponding domain.
The effects of LCZ696 compared to valsartan on the individual cognitive domains (memory, executive function, and attention) over 3 years were evaluated by assessing the individual components of the CogState cognitive battery. Composite scores for the 3 individual cognitive domains were generated by combining the standardized z-scores of selected tests from the CogState cognitive battery. Each composite score was the average of the non-missing individual test z-scores. A higher score indicated better cognitive function.
Outcome measures
| Measure |
LCZ696 200 mg Bid
n=197 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=185 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|
|
Change From Baseline in Individual Cognitive Domains
Memory domain
|
-0.0573 Z-scores
Standard Error 0.0477
|
-0.0580 Z-scores
Standard Error 0.0490
|
|
Change From Baseline in Individual Cognitive Domains
Executive function domain
|
-0.0375 Z-scores
Standard Error 0.0480
|
-0.0702 Z-scores
Standard Error 0.0493
|
|
Change From Baseline in Individual Cognitive Domains
Attention domain
|
-0.1836 Z-scores
Standard Error 0.0614
|
-0.0794 Z-scores
Standard Error 0.0634
|
SECONDARY outcome
Timeframe: Baseline, month 36Population: The overall number of participants analyzed represents the participants in the Safety Set (SAF) with non-missing value at both, baseline and month 36.
The effects of LCZ696 compared to valsartan on the changes in IADL over 3 years were evaluated by as assessing the Functional activities questionnaire (FAQ) summary scores. The FAQ is a 30-point questionnaire that is made up of 10 questions that reflect a patient's ability to perform activities of daily living and to function independently. A score of 0 represents no impairment and a score of 30 represents severe impairment.
Outcome measures
| Measure |
LCZ696 200 mg Bid
n=197 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=186 Participants
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|
|
Change From Baseline in the Summary Score of the Instrumental Activities of Daily Living (IADL)
|
0.5983 FAQ scores
Standard Error 0.2064
|
0.7089 FAQ scores
Standard Error 0.2115
|
Adverse Events
Valsartan Run-in 40 mg Bid
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Valsartan Run-in 80 mg Bid
Serious events: 6 serious events
Other events: 76 other events
Deaths: 1 deaths
LCZ696 Run-in 100 mg Bid
Serious events: 27 serious events
Other events: 136 other events
Deaths: 2 deaths
LCZ696 200 mg Bid
Serious events: 145 serious events
Other events: 238 other events
Deaths: 28 deaths
Valsartan 160 mg Bid
Serious events: 161 serious events
Other events: 245 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Valsartan Run-in 40 mg Bid
n=318 participants at risk
Treatment run-in with valsartan 40 mg bid (if necessary)
|
Valsartan Run-in 80 mg Bid
n=675 participants at risk
Treatment run-in with valsartan 80 mg bid
|
LCZ696 Run-in 100 mg Bid
n=659 participants at risk
Treatment run-in with LCZ696 100 mg bid
|
LCZ696 200 mg Bid
n=295 participants at risk
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=297 participants at risk
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour in the large intestine
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial stromal sarcoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Headache
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Syncope
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Urinary retention
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Central sleep apnoea syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.1%
9/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypertension
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypotension
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Thrombasthenia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.7%
14/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.7%
11/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrial flutter
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.1%
15/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.1%
15/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Ear and labyrinth disorders
Chondrodermatitis nodularis chronica helicis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Cataract
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Glaucoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Asthenia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Cardiac death
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Chest pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Death
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Fatigue
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Generalised oedema
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Impaired healing
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Oedema
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Oedema peripheral
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Pyrexia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Strangulated hernia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Sudden death
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Cardiac cirrhosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
COVID-19
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Candida infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Cystitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Device related infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Gangrene
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Influenza
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Orchitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Pneumonia
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Sepsis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Septic shock
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Viral infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Wound infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Auricular haematoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Angiocardiogram
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Blood glucose increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Catheterisation cardiac abnormal
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Liver function test increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Procalcitonin increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Rubulavirus test positive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Viral test positive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Weight decreased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Weight increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatobiliary neoplasm
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
Other adverse events
| Measure |
Valsartan Run-in 40 mg Bid
n=318 participants at risk
Treatment run-in with valsartan 40 mg bid (if necessary)
|
Valsartan Run-in 80 mg Bid
n=675 participants at risk
Treatment run-in with valsartan 80 mg bid
|
LCZ696 Run-in 100 mg Bid
n=659 participants at risk
Treatment run-in with LCZ696 100 mg bid
|
LCZ696 200 mg Bid
n=295 participants at risk
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years.
|
Valsartan 160 mg Bid
n=297 participants at risk
Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given valsartan at 160 mg twice daily for three years.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.1%
24/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.1%
21/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.4%
16/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.8%
17/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.4%
22/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Bradycardia
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.7%
14/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.4%
25/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
6.1%
18/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Eye disorders
Cataract
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
6.4%
19/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
6/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Asthenia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Fatigue
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.1%
7/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.4%
16/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.7%
23/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Non-cardiac chest pain
|
0.63%
2/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.1%
9/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Oedema peripheral
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.1%
24/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.4%
25/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
General disorders
Pyrexia
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.59%
4/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
6.1%
18/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
COVID-19
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.1%
12/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Cystitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.67%
2/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.74%
5/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.2%
8/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.8%
26/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.4%
25/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.7%
11/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Sinusitis
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.1%
9/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.63%
2/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
2/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.8%
26/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.1%
21/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Fall
|
0.94%
3/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.44%
3/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
6.4%
19/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.1%
15/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.1%
9/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Blood pressure increased
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
Glomerular filtration rate decreased
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.59%
4/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.1%
15/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.4%
16/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.68%
2/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Gout
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.1%
9/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.94%
3/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.6%
11/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.2%
8/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
10.5%
31/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
13.8%
41/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.7%
14/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.63%
2/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.59%
4/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.91%
6/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.5%
25/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
10.8%
32/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.76%
5/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.5%
22/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
9.4%
28/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.1%
12/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.7%
11/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Dizziness
|
1.6%
5/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.59%
4/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
11/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
9.5%
28/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
10.4%
31/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Headache
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.59%
4/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.7%
11/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Nervous system disorders
Syncope
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.3%
4/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Psychiatric disorders
Depression
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
4/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.7%
14/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.4%
13/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Renal failure
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.44%
3/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.61%
4/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.7%
5/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.4%
7/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
8.8%
26/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
10.4%
31/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.4%
10/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.44%
3/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.4%
9/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
5.8%
17/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
4.0%
12/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.1%
21/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
11.4%
34/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.63%
2/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.94%
3/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.7%
8/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.15%
1/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.46%
3/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.0%
3/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.0%
9/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.00%
0/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.34%
1/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
2.0%
6/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypertension
|
0.00%
0/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
0.30%
2/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
7.1%
21/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
10.4%
31/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
|
Vascular disorders
Hypotension
|
2.8%
9/318 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
1.5%
10/675 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
3.6%
24/659 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
23.1%
68/295 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
19.2%
57/297 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 37 months.
The analysis considered patients in the Enrolled set (ENR) for AEs reported during the run-in epoch and Safety set (SAF) for reported AEs during the double-blind randomized treatment epoch.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER