Trial Outcomes & Findings for Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes (NCT NCT00102687)
NCT ID: NCT00102687
Last Updated: 2019-11-22
Results Overview
Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD). Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by \>=50% or a less advanced FAB classification from pretreatment (see Population Descrip)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Day 1 (randomization) to 6 months
Results posted on
2019-11-22
Participant Flow
One hundred and eighty-four patients were screened.
Participant milestones
| Measure |
Aza-5
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
Maintenance Aza 5 Days q 4 Weeks
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks from month 7 to month 23
|
Maintenance Aza 5 Days q 6 Weeks
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks from month 7 to month 23
|
|---|---|---|---|---|---|
|
Initial Period
STARTED
|
50
|
50
|
51
|
0
|
0
|
|
Initial Period
COMPLETED
|
32
|
22
|
25
|
0
|
0
|
|
Initial Period
NOT COMPLETED
|
18
|
28
|
26
|
0
|
0
|
|
Maintenance Period
STARTED
|
13
|
6
|
8
|
22
|
21
|
|
Maintenance Period
COMPLETED
|
6
|
2
|
2
|
12
|
8
|
|
Maintenance Period
NOT COMPLETED
|
7
|
4
|
6
|
10
|
13
|
Reasons for withdrawal
| Measure |
Aza-5
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
Maintenance Aza 5 Days q 4 Weeks
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks from month 7 to month 23
|
Maintenance Aza 5 Days q 6 Weeks
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks from month 7 to month 23
|
|---|---|---|---|---|---|
|
Initial Period
Withdrawal by Subject
|
6
|
3
|
5
|
0
|
0
|
|
Initial Period
Adverse Event
|
4
|
7
|
9
|
0
|
0
|
|
Initial Period
Transformation to AML (blast > 30%)
|
1
|
3
|
0
|
0
|
0
|
|
Initial Period
Protocol Violation
|
0
|
0
|
2
|
0
|
0
|
|
Initial Period
Physician Decision
|
2
|
9
|
6
|
0
|
0
|
|
Initial Period
Sponsor's decision
|
0
|
1
|
1
|
0
|
0
|
|
Initial Period
Failed Treatments (relapse,disease prog)
|
4
|
4
|
2
|
0
|
0
|
|
Initial Period
Death
|
1
|
1
|
1
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
4
|
0
|
2
|
3
|
1
|
|
Maintenance Period
Adverse Event
|
1
|
0
|
0
|
1
|
3
|
|
Maintenance Period
Transformation to AML (blast > 30%)
|
0
|
1
|
0
|
2
|
0
|
|
Maintenance Period
Failed Treatment (relapse,disease prog)
|
1
|
1
|
1
|
3
|
4
|
|
Maintenance Period
Death
|
0
|
0
|
0
|
1
|
1
|
|
Maintenance Period
Physician Decision
|
1
|
2
|
3
|
0
|
4
|
Baseline Characteristics
Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
76.0 years
n=5 Participants
|
73.0 years
n=7 Participants
|
76.0 years
n=5 Participants
|
75.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
ECOG Performance Status
0=Fully active
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
ECOG Performance Status
1=Restricted
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
ECOG Performance Status
2=Ambulatory/capable of self care
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
ECOG Performance Status
3=Capable/limited care
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
FAB Classification
RA
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
FAB Classification
RARS
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
FAB Classification
RAEB
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
FAB Classification
RAEB-T
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
FAB Classification
CMMoL with <5% blasts
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
FAB Classification
CMMoL with >=5% blasts
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
FAB Classification
CMMoL with missing blasts
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
FAB Classification
AML
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
FAB Classification
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Transfusion Dependence - Platelets
Platelet transfusion dependent
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Transfusion Dependence - Platelets
Not platelet transfusion dependent
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Transfusion Dependence Status - RBCs
RBC transfusion dependent
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Transfusion Dependence Status - RBCs
Not RBC transfusion dependent
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (randomization) to 6 monthsPopulation: Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response. (Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months.
Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD). Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by \>=50% or a less advanced FAB classification from pretreatment (see Population Descrip)
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Overall Response (CR+PR)
|
4 participants
|
3 participants
|
4 participants
|
|
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Partial remission (PR)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Complete remission (CR)
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Stable disease
|
22 participants
|
19 participants
|
20 participants
|
PRIMARY outcome
Timeframe: Day 1 (randomization) to 6 monthsPopulation: Intent to treat population. Patients count only once for best response within an improvement category. (Outcome Description continued) Neutrophil response: Major-\>=100% increase in neutrophil count or an absolute increase of \>0.5x10\^9/L. Minor-\>=100% increase but an absolute increase of \<0.5x10\^9/L.
IWG 2000 Criteria: Pretreatment=hemoglobin \<110g/L or RBC transfusion-dependence, platelet count \<100x10\^9/L or platelet transfusion dependence, absolute neutrophil count \<1.5x10\^9/L. Erythroid response: Major-\>20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or \>=50% decrease in transfusion requirements. Platelet response: Major-absolute increase of platelet count by \>=30x10\^9/L or platelet transfusion independence. Minor-\>=50% increase in platelet count with net increase \>10x10\^9/L but \<30x10\^9/L. (continued in Population Description)
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Any Improvement n=50,49,47
|
29 participants
|
20 participants
|
26 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Erythroid response - Major n=44,43,41
|
18 participants
|
15 participants
|
18 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Erythroid response - Minor n=44,43,41
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Platelet response - Major n=24,28,28
|
10 participants
|
11 participants
|
10 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Platelet response - Minor n=24,28,28
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Neutrophil response - Major n=24,22,16
|
4 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Neutrophil response - Minor n=24,22,16
|
2 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 (randomization) to 6 monthsPopulation: Intent to treat population
Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period
|
30 participants
|
20 participants
|
27 participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population.
Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=27 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period
Improved response from initial study period
|
7 participants
|
10 participants
|
12 participants
|
|
Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period
Maintained response from initial study period
|
6 participants
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Day 1 (randomization)Population: Intent to treat population
The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=50 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Baseline Hemoglobin Values
|
94.0 g/L
Interval 63.0 to 131.0
|
98.0 g/L
Interval 70.0 to 135.0
|
95.5 g/L
Interval 59.0 to 145.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=46 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)
|
2.3 g/L
Interval -25.9 to 41.8
|
2.9 g/L
Interval -33.0 to 31.7
|
5.3 g/L
Interval -20.4 to 30.4
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=26 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin at the End of the Maintenance Study Period
|
5.9 g/L
Interval -27.9 to 54.8
|
7.3 g/L
Interval -14.4 to 55.5
|
14.5 g/L
Interval -5.5 to 60.4
|
SECONDARY outcome
Timeframe: Day 1 (randomization)Population: Intent to treat population
The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.
Outcome measures
| Measure |
Aza-5
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=49 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Baseline Platelet Values
|
110.0 x10(9)/L
Interval 9.0 to 516.0
|
90.0 x10(9)/L
Interval 8.0 to 581.0
|
86.0 x10(9)/L
Interval 8.0 to 699.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
The difference between platelet values at the end of the initial study period minus the platelet values at baseline.
Outcome measures
| Measure |
Aza-5
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=45 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Platelets at the End of Initial Study Period (6 Months)
|
4.8 x10^9/L
Interval -116.3 to 179.1
|
5.7 x10^9/L
Interval -145.6 to 192.6
|
12.6 x10^9/L
Interval -300.9 to 213.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=26 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)
|
19.8 x10^9/L
Interval -157.5 to 129.6
|
7.7 x10^9/L
Interval -279.8 to 166.3
|
17.3 x10^9/L
Interval -124.7 to 223.3
|
SECONDARY outcome
Timeframe: Day 1 (randomization)Population: Intent to treat population
The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=50 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Baseline Absolute Neutrophil Count (ANC) Values
|
1.6 x10^9/L
Interval 0.1 to 13.9
|
1.9 x10^9/L
Interval 0.1 to 162.3
|
2.3 x10^9/L
Interval 0.3 to 139.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
The difference between ANC values at the end of the initial study period minus the ANC values at baseline.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=49 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=46 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)
|
-0.3 x10^9/L
Interval -4.6 to 1.9
|
-0.3 x10^9/L
Interval -35.9 to 1.4
|
-0.4 x10^9/L
Interval -9.7 to 8.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=26 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)
|
-0.1 x10^9/L
Interval -17.6 to 2.0
|
-0.2 x10^9/L
Interval -3.1 to 1.9
|
-0.4 x10^9/L
Interval -19.0 to 2.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Dependent(n=25,24,22) - 6 mo Independent
|
16 participants
|
14 participants
|
13 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Dependent(n=25,24,22) - 6 mo Dependent
|
9 participants
|
10 participants
|
9 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Independent(n=25,26,29)- 6 mo Independent
|
19 participants
|
16 participants
|
19 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Independent(n=25,26,29) - 6 mo Dependent
|
6 participants
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=51 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Dependent (n=4,2,1) - 6 mo Independent
|
3 participants
|
2 participants
|
0 participants
|
|
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Dependent (n=4,2,1) - 6 mo Dependent
|
1 participants
|
0 participants
|
1 participants
|
|
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Independent(n=46,48,50)- 6 mo Independent
|
43 participants
|
42 participants
|
41 participants
|
|
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Baseline Independent (n=46,48,50) - 6 mo Dependent
|
3 participants
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=27 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Dependent (n=6,12,12) - 24 mo Independent
|
5 participants
|
12 participants
|
10 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Dependent (n=6,12,12) - 24 mo Dependent
|
1 participants
|
0 participants
|
2 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Independent(n=16,9,15)- 24 mo Independent
|
15 participants
|
9 participants
|
15 participants
|
|
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Independent (n=16,9,15) - 24 mo Dependent
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=27 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Independent(n=21,20,25) - 24 mo Dependent
|
0 participants
|
0 participants
|
0 participants
|
|
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Dependent (n=1,1,2) - 24 mo Independent
|
1 participants
|
1 participants
|
2 participants
|
|
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Dependent (n=1,1,2) - 24 mo Dependent
|
0 participants
|
0 participants
|
0 participants
|
|
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Baseline Independent(n=21,20,25)-24 mo Independent
|
21 participants
|
20 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
Outcome measures
| Measure |
Aza-5
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=48 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period
|
0.00 infections per cycle
Interval 0.0 to 1.0
|
0.00 infections per cycle
Interval 0.0 to 1.0
|
0.00 infections per cycle
Interval -0.89 to 7.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
Outcome measures
| Measure |
Aza-5
n=22 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=21 Participants
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=27 Participants
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
|---|---|---|---|
|
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period
|
0.00 infections per cycle
Interval -1.0 to 0.0
|
0.00 infections per cycle
Interval 0.0 to 0.2
|
0.00 infections per cycle
Interval 0.0 to 0.67
|
Adverse Events
Aza-5
Serious events: 18 serious events
Other events: 49 other events
Deaths: 0 deaths
Aza-5-2-2
Serious events: 27 serious events
Other events: 50 other events
Deaths: 0 deaths
Aza-5-2-5
Serious events: 22 serious events
Other events: 46 other events
Deaths: 0 deaths
Maintenance Aza 5 Days q 4 Weeks
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Maintenance Aza 5 Days q 6 Weeks
Serious events: 13 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aza-5
n=50 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=48 participants at risk
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
Maintenance Aza 5 Days q 4 Weeks
n=22 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks from month 7 to month 23
|
Maintenance Aza 5 Days q 6 Weeks
n=21 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks from month 7 to month 23
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Cardiac valve vegetation
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Chest pain
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Fatigue
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Pyrexia
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Hepatobiliary disorders
Bile duct stone
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Hepatobiliary disorders
Cholangitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Candida sepsis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Enterobacter bacteraemia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Enterococcal sepsis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Escherichia bacteraemia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Fungal oesophagitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Herpes zoster disseminated
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.4%
5/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Septic shock
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Renal and urinary disorders
Calculus urinary
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Reproductive system and breast disorders
Vaginal polyp
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
Other adverse events
| Measure |
Aza-5
n=50 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle.
|
Aza-5-2-2
n=50 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
|
Aza-5-2-5
n=48 participants at risk
Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
|
Maintenance Aza 5 Days q 4 Weeks
n=22 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks from month 7 to month 23
|
Maintenance Aza 5 Days q 6 Weeks
n=21 participants at risk
Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks from month 7 to month 23
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.0%
11/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
34.0%
17/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
25.0%
12/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
23.8%
5/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
20.0%
10/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
18.8%
9/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
15/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
44.0%
22/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
35.4%
17/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
28.0%
14/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
25.0%
12/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
23.8%
5/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.5%
6/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Constipation
|
56.0%
28/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
50.0%
25/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
43.8%
21/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.0%
13/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
30.0%
15/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
29.2%
14/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
23.8%
5/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Nausea
|
62.0%
31/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
62.0%
31/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
47.9%
23/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
28.6%
6/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
18/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
27.1%
13/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Asthenia
|
20.0%
10/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.7%
8/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
19.0%
4/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Chest pain
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Chills
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Fatigue
|
50.0%
25/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
60.0%
30/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
60.4%
29/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
22.7%
5/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site bruising
|
22.0%
11/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
18.0%
9/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site desquamation
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site erythema
|
56.0%
28/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
56.0%
28/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
54.2%
26/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site inflammation
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site nodule
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site pain
|
30.0%
15/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
36.0%
18/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
37.5%
18/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site pruritus
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site rash
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site urticaria
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Injection site warmth
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Oedema peripheral
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
28.0%
14/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
33.3%
16/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Pain
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
General disorders
Pyrexia
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
20.8%
10/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
23.8%
5/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Oral herpes
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Infections and infestations
Urinary tract infection
|
18.0%
9/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.5%
6/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.6%
7/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Investigations
Blood urea increased
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Investigations
Weight decreased
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
26.0%
13/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.5%
6/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.4%
5/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.5%
1/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
19.0%
4/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Dizziness
|
22.0%
11/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
22.9%
11/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Headache
|
26.0%
13/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.6%
7/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Psychiatric disorders
Insomnia
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
18.0%
9/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.4%
5/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.4%
5/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
13.6%
3/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
34.0%
17/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
22.0%
11/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
18.8%
9/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.5%
6/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.4%
5/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.8%
1/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
10.0%
5/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
6.2%
3/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.5%
6/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
14.0%
7/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.0%
12/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
16.0%
8/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
8.3%
4/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.5%
2/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
9.1%
2/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Vascular disorders
Hypotension
|
8.0%
4/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
12.0%
6/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.2%
2/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
14.3%
3/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
|
Vascular disorders
Pallor
|
6.0%
3/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
4.0%
2/50 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
2.1%
1/48 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/22 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
0.00%
0/21 • The 3 groups in the Initial Period cover Day 1-6 months, and up to 24 months for participants that continued that treatment. The 2 Maintenance Period groups cover months 7-24 for subjects who were randomized to 1 of the 2 Maintenance treatment arms.
Safety population includes participants who received study treatment. Treatment emergent AEs include events within 42 days of the date of last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i)furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
- Publication restrictions are in place
Restriction type: OTHER