Trial Outcomes & Findings for A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. (NCT NCT04711603)
NCT ID: NCT04711603
Last Updated: 2025-09-10
Results Overview
The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
178 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-10
Participant Flow
Two hundred thirty subjects were screened. A total of 178 subjects included in the study and were randomly assigned to the study drug. The number of subjects in the double-blind period (6 weeks) was 178. The number of subjects who transitioned to the extension period (52 weeks) was 168. The number of subjects who completed Week 58 was 122.
Previously treated hemodialysis patients with pruritus were enrolled in a 1:1 ratio to either MR13A9 0.5 μg/kg group or Placebo group. Subjects who received placebo in the double-blind period received MR13A9 0.5 μg/kg in the extension period.
Participant milestones
| Measure |
Double Blind Period: MR13A9 0.5 μg/kg Group
MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Double Blind Period: Placebo Group
Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 0 μg
2. \>=45.0 kg, \<65.0 kg: 0 μg
3. \>=65.0 kg, \<85.0 kg: 0 μg
4. \>=85.0 kg: 0 μg
|
Entire Study: MR13A9/MR13A9 Group
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.
\[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Entire Study: Placebo/MR13A9 Group
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.
\[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
|---|---|---|---|---|
|
Double-blind Period (6 Weeks)
STARTED
|
89
|
89
|
0
|
0
|
|
Double-blind Period (6 Weeks)
COMPLETED
|
85
|
83
|
0
|
0
|
|
Double-blind Period (6 Weeks)
NOT COMPLETED
|
4
|
6
|
0
|
0
|
|
Extension Period (52 Weeks)
STARTED
|
0
|
0
|
85
|
83
|
|
Extension Period (52 Weeks)
COMPLETED
|
0
|
0
|
68
|
54
|
|
Extension Period (52 Weeks)
NOT COMPLETED
|
0
|
0
|
17
|
29
|
Reasons for withdrawal
| Measure |
Double Blind Period: MR13A9 0.5 μg/kg Group
MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Double Blind Period: Placebo Group
Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 0 μg
2. \>=45.0 kg, \<65.0 kg: 0 μg
3. \>=65.0 kg, \<85.0 kg: 0 μg
4. \>=85.0 kg: 0 μg
|
Entire Study: MR13A9/MR13A9 Group
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.
\[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Entire Study: Placebo/MR13A9 Group
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.
\[Extension period (52 weeks)\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
|---|---|---|---|---|
|
Double-blind Period (6 Weeks)
Adverse Event
|
4
|
3
|
0
|
0
|
|
Double-blind Period (6 Weeks)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Double-blind Period (6 Weeks)
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Double-blind Period (6 Weeks)
4 consecutive missed doses of the study drug
|
0
|
1
|
0
|
0
|
|
Extension Period (52 Weeks)
Adverse Event
|
0
|
0
|
6
|
18
|
|
Extension Period (52 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Extension Period (52 Weeks)
Withdrawal by Subject
|
0
|
0
|
4
|
5
|
|
Extension Period (52 Weeks)
7 consecutive missed doses of the study drug
|
0
|
0
|
5
|
2
|
|
Extension Period (52 Weeks)
Needed to prioritize the treatment of adverse events
|
0
|
0
|
0
|
1
|
|
Extension Period (52 Weeks)
Difficulty in using iPad for efficacy evaluation
|
0
|
0
|
0
|
1
|
|
Extension Period (52 Weeks)
The input rate of the symptom diary was low and no improvement
|
0
|
0
|
0
|
1
|
|
Extension Period (52 Weeks)
Transferred to another hospital
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Baseline characteristics by cohort
| Measure |
MR13A9 0.5 μg/kg Group
n=85 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug (MR13A9) was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Placebo Group
n=88 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Age, Customized
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
85 participants
n=5 Participants
|
88 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
Dry Weight at the start of Screening
|
62.64 kg
STANDARD_DEVIATION 11.63 • n=5 Participants
|
63.33 kg
STANDARD_DEVIATION 12.94 • n=7 Participants
|
62.99 kg
STANDARD_DEVIATION 12.28 • n=5 Participants
|
|
Hemodialysis History
|
8.4 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
8.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Disease Duration of Itch
|
5.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
4.6 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Average NRS Score
|
6.57 points
STANDARD_DEVIATION 1.29 • n=5 Participants
|
6.40 points
STANDARD_DEVIATION 1.28 • n=7 Participants
|
6.48 points
STANDARD_DEVIATION 1.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Outcome measures
| Measure |
MR13A9 0.5 μg/kg Group
n=85 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug (MR13A9) was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Placebo Group
n=88 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
|
|---|---|---|
|
Change From Baseline in the Mean NRS Score at Week 4
|
-2.06 points
Standard Error 0.20
|
-1.09 points
Standard Error 0.20
|
Adverse Events
Double Blind Period: MR13A9 0.5 μg/kg Group
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Double Blind Period: Placebo Group
Serious events: 10 serious events
Other events: 24 other events
Deaths: 1 deaths
Entire Study: MR-MR Group
Serious events: 33 serious events
Other events: 74 other events
Deaths: 2 deaths
Entire Study: P-MR Group
Serious events: 38 serious events
Other events: 74 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Double Blind Period: MR13A9 0.5 μg/kg Group
n=89 participants at risk
MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Double Blind Period: Placebo Group
n=89 participants at risk
Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 0 μg
2. \>=45.0 kg, \<65.0 kg: 0 μg
3. \>=65.0 kg, \<85.0 kg: 0 μg
4. \>=85.0 kg: 0 μg
|
Entire Study: MR-MR Group
n=85 participants at risk
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.
\[Extension period (52 weeks)\]
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Entire Study: P-MR Group
n=83 participants at risk
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.
\[Extension period (52 weeks)\]
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/85 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/83 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Eye disorders
Cataract
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/83 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Anal prolapse
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Gastric polyps
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
General disorders
Malaise
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/83 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/85 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/83 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/85 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
4.8%
4/83 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Sepsis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Shunt infection
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/83 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.1%
6/85 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
4.8%
4/83 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
4.5%
4/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.4%
2/85 • Number of events 7 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
8.4%
7/83 • Number of events 18 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Investigations
Blood pressure decreased
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/83 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Vascular disorders
Aortic stenosis
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.5%
3/85 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.6%
3/83 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/83 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
Other adverse events
| Measure |
Double Blind Period: MR13A9 0.5 μg/kg Group
n=89 participants at risk
MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Double Blind Period: Placebo Group
n=89 participants at risk
Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).
The dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.
1. \<45.0 kg: 0 μg
2. \>=45.0 kg, \<65.0 kg: 0 μg
3. \>=65.0 kg, \<85.0 kg: 0 μg
4. \>=85.0 kg: 0 μg
|
Entire Study: MR-MR Group
n=85 participants at risk
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.
\[Extension period (52 weeks)\]
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
Entire Study: P-MR Group
n=83 participants at risk
\[Double-blind period (6 weeks)\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.
\[Extension period (52 weeks)\]
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).
The dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.
1. \<45.0 kg: 17.5 μg
2. \>=45.0 kg, \<65.0 kg: 25.0 μg
3. \>=65.0 kg, \<85.0 kg: 35.0 μg
4. \>=85.0 kg: 42.5 μg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.5%
4/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
14.1%
12/85 • Number of events 13 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.6%
8/83 • Number of events 11 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.4%
3/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
12.9%
11/85 • Number of events 18 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
21.7%
18/83 • Number of events 26 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.2%
1/85 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
8.2%
7/85 • Number of events 16 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.4%
8/85 • Number of events 8 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.6%
3/83 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
General disorders
Pyrexia
|
4.5%
4/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
17.6%
15/85 • Number of events 17 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
21.7%
18/83 • Number of events 20 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
General disorders
Vaccination site pain
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 7 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.6%
3/83 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
3/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
15.3%
13/85 • Number of events 25 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
18.1%
15/83 • Number of events 22 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/85 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
17.6%
15/85 • Number of events 20 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
8.4%
7/83 • Number of events 8 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 8 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.2%
6/83 • Number of events 8 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
5.6%
5/89 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
12.9%
11/85 • Number of events 15 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.6%
8/83 • Number of events 16 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.4%
8/85 • Number of events 12 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
14.5%
12/83 • Number of events 18 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
16.5%
14/85 • Number of events 19 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
14.5%
12/83 • Number of events 17 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.5%
3/85 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
4.7%
4/85 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
6.0%
5/83 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.4%
8/85 • Number of events 9 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.2%
6/83 • Number of events 7 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
12.9%
11/85 • Number of events 11 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
12.0%
10/83 • Number of events 12 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.4%
3/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
4.7%
4/85 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
10.8%
9/83 • Number of events 12 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.2%
2/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
10.6%
9/85 • Number of events 10 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
9.6%
8/83 • Number of events 12 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.4%
3/89 • Number of events 4 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 7 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
10.8%
9/83 • Number of events 11 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Nervous system disorders
Headache
|
2.2%
2/89 • Number of events 3 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.1%
6/85 • Number of events 8 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
12.0%
10/83 • Number of events 14 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.2%
6/83 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
2.2%
2/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
7.1%
6/85 • Number of events 6 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
8.4%
7/83 • Number of events 10 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 2 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
5.9%
5/85 • Number of events 7 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.6%
3/83 • Number of events 5 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
|
Vascular disorders
Dialysis hypotension
|
0.00%
0/89 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
1.1%
1/89 • Number of events 1 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
3.5%
3/85 • Number of events 9 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
10.8%
9/83 • Number of events 10 • Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)
Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email olly
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place