Trial Outcomes & Findings for A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia (NCT NCT00506441)
NCT ID: NCT00506441
Last Updated: 2026-01-08
Results Overview
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
4 weeks (Week 12 to Week 16)
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
MCI-196
Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
Placebo
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
|---|---|---|
|
Period 1; Open-label Period
STARTED
|
245
|
0
|
|
Period 1; Open-label Period
COMPLETED
|
169
|
0
|
|
Period 1; Open-label Period
NOT COMPLETED
|
76
|
0
|
|
Period 2; Double-blind Period
STARTED
|
85
|
84
|
|
Period 2; Double-blind Period
COMPLETED
|
82
|
79
|
|
Period 2; Double-blind Period
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
MCI-196
Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
Placebo
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
|---|---|---|
|
Period 1; Open-label Period
Adverse Event
|
21
|
0
|
|
Period 1; Open-label Period
Lack of Efficacy
|
13
|
0
|
|
Period 1; Open-label Period
Lost to Follow-up
|
2
|
0
|
|
Period 1; Open-label Period
Physician Decision
|
5
|
0
|
|
Period 1; Open-label Period
Protocol Violation
|
9
|
0
|
|
Period 1; Open-label Period
Withdrawal by Subject
|
13
|
0
|
|
Period 1; Open-label Period
Other Reasons
|
13
|
0
|
|
Period 2; Double-blind Period
Adverse Event
|
0
|
1
|
|
Period 2; Double-blind Period
Lack of Efficacy
|
0
|
2
|
|
Period 2; Double-blind Period
Physician Decision
|
1
|
1
|
|
Period 2; Double-blind Period
Withdrawal by Subject
|
1
|
0
|
|
Period 2; Double-blind Period
Other Reason
|
1
|
1
|
Baseline Characteristics
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
MCI-196
n=245 Participants
Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 12.9 • n=18 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (Week 12 to Week 16)Population: Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Outcome measures
| Measure |
MCI-196 (Double-blind Period)
n=85 Participants
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
Placebo (Double-blind Period)
n=83 Participants
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
|---|---|---|
|
The Change in Serum Phosphorus From Week 12 to Week 16
|
-0.04 mg / dL
Standard Deviation 1.49 • Interval -1.45 to -0.57
|
0.71 mg / dL
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: 12 weeks (Week 0 to Week 12)Population: ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)
Outcome measures
| Measure |
MCI-196 (Double-blind Period)
n=241 Participants
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
Placebo (Double-blind Period)
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus
|
-1.54 mg/dL
Interval -1.8 to -1.28
|
—
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)Outcome measures
Outcome data not reported
Adverse Events
MCI-196 (Open-label Period)
Serious events: 37 serious events
Other events: 161 other events
Deaths: 0 deaths
MCI-196 (Double-blind Period)
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo (Double-blind Period)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-196 (Open-label Period)
n=245 participants at risk
3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
|
MCI-196 (Double-blind Period)
n=86 participants at risk
dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period.
|
Placebo (Double-blind Period)
n=83 participants at risk
dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Sepsis
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Pneumonia
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.3%
2/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Subcutaneous abscess
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Cellulitis
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Bronchitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Staphylococcal infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Osteomyelitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Gangrene
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Non-cardiac chest pain
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Pyrexia
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Catheter site haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Chest pain
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Duodenitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Gastritis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Peritonitis
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Syncope
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Hypertension
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Hypotension
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Angina unstable
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Myocardial infarction
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Atrial fibrillation
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Bradycardia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiomyopathy
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Angina pectoris
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Pericarditis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Liver function test abnormal
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Colonoscopy abnormal
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Delirium
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Renal and urinary disorders
Renal cyst
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Septic shock
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Endocrine disorders
Goitre
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
Other adverse events
| Measure |
MCI-196 (Open-label Period)
n=245 participants at risk
3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
|
MCI-196 (Double-blind Period)
n=86 participants at risk
dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period.
|
Placebo (Double-blind Period)
n=83 participants at risk
dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Cellulitis
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.4%
2/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Hordeolum
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.4%
2/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Influenza
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
4.5%
11/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Fall
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Diverticulitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.6%
3/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Tooth infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
9/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Gastroenteritis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Bronchitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Ear infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Lymphangitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Hepatitis C
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Fungal infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Localised infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Eyelid infection
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
21/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
4.7%
4/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
22/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.5%
3/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.6%
3/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Diverticulum
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Melaena
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
12/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
18/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.5%
3/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
15/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Dry mouth
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Flatulence
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Peritonitis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.3%
2/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
11/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Vision blurred
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Conjunctivitis
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Visual impairment
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Lacrimation increased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Cataract
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Eye haemorrhage
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Ocular hyperaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Eye disorders
Eye swelling
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
11/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
8/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.5%
3/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiac failure acute
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Sinus tachycardia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Conduction disorder
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Bradycardia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Chills
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Malaise
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Oedema peripheral
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.5%
3/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Chest pain
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Pyrexia
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Asthenia
|
2.9%
7/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Fatigue
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.3%
2/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Gait disturbance
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Generalised oedema
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Oedema
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.3%
2/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Influenza like illness
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Tenderness
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
General disorders
Face oedema
|
1.2%
3/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Hypotension
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Hypertension
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Haematoma
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Hot flush
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Sinus headache
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Headache
|
4.1%
10/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
2.4%
2/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Paraesthesia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Syncope
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Somnolence
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Dizziness postural
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Dizziness
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
3.5%
3/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Restless legs syndrome
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Nervous system disorders
Dysgeusia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood phosphorus increased
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood phosphorus decreased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Body temperature increased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Prothrombin time prolonged
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Weight decreased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood triglycerides increased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Carbon dioxide decreased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
High density lipoprotein decreased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Urine output decreased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Very low density lipoprotein increased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Vitamin D decreased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood calcium decreased
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Blood parathyroid hormone increased
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Cardiac murmur
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
6/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Anxiety
|
1.6%
4/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Insomnia
|
2.0%
5/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Sleep disorder
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Mental status changes
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Psychiatric disorders
Disorientation
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Endocrine disorders
Hypothyroidism
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Immune system disorders
Drug hypersensitivity
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Immune system disorders
Seasonal allergy
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Renal and urinary disorders
Dysuria
|
0.82%
2/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.41%
1/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Infections and infestations
Eye infection
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Investigations
Osteocalcin increased
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/245 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
1.2%
1/86 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
0.00%
0/83 • 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16)
Open-label Period is 12 weeks from Week 0 to Week 12. Double-Blind Period is 4 weeks after randomization at Week 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER